break out 1 a systematic reviews fric ton

James Fricton DDS, MSProfessor

University of Minnesota School of DentistryHealthPartners Research FoundationMinnesota Head & Neck Pain Clinic

Systematic Reviews of Efficacy of TMD Treatment

The Translation of Scientific Evidence into Successful Management of TMD Patients

• Encourage clinicians to use of treatments that work and reduce use of treatments/ tests that do not work.

• Encourage clinicians to understand factors that contribute to treatment failure

• Identify the risk/ benefit ratio and minimize adverse events

• Insurers using EBC in decisions to cover a particular treatment or not

• Encourage RCT studies to be done on new treatments and tests and develop a high standard for evaluating new treatments by FDA.

Questions about TMD Treatments

• What treatments have an active therapeutic effect beyond placebo?

• How well does a treatment work compared to another treatment or no treatment?

• What patient characteristics or diagnostic subtype does the treatment work best with?

• What are the risks/ adverse events related to treatment and do the benefits outweigh the risks?

• What factors contribute to delayed healing and recovery

44 or more different TMD treatments with over 150 clinical trials with diversity in;• Study designs

• Treatment techniques

• Study populations

• Outcome measures

• Success rates

Reviewing the TMD scientific literature

Clinicians are faced a confusing array of available literature if they choose to make evidence-based clinical decisions

• Identify either meta-analysis of RCT or treatments

with at least one randomized clinical trial (RCTs)

• Compare the outcomes and characteristics of RCTs

• Evaluate the quality of methods used in each RCT

• Capture results qualitatively and quantitatively

• Conduct meta-analysis and Forrest Plot when

possible

Methods for Systematic Review ofTMD Treatment

Acknowledgements

ContributorsJames Fricton, D.D.S., M.S.Edward Wright D.D.S., M.S. John Look, D.D.S., Ph.D.Robert Rosenbaum D.M.D.Hong Chen D.D.S.Karen Decker R.P.T.Maureen Lang D.D.S., M.S.James Luderitz D.D.S., M.S.Mariona Mulet D.D.S., M.S.Francisco Alencar D.D.S.,M.S. Wei Ouyang D.D.S., M.S.Gary Anderson D.D.S.,M.S.

ConsultantsKathy Robbins, B.A. InformaticsRichard Niederman, D.D.S, Ph.D.Wenjun Kang M.S. Informatics

SponsorsAmerican Academy of Orofacial PainNIDCR’s TMJ Implant Registry and RepositoryNIH-NIDCR Contract No. N01-DE-22635NIH-NIDCR R01 No. DE11252-03University of Minnesota School of Dentistry

A MEDLINE search strategy was developed to include the years 1966-2006 and implemented on the PubMedinterface for MEDLINE at the US National Library of Medicine and include all TMD terms (http://www.ncbi.nlm.nih.gov/PubMed/).

Based on the recommendations of the US Agency for Health Care Policy and Research and the Centre for Evidence-based Medicine (http://cebm.jr2.ox.ac.uk/doc/levels.html)

Manual searches of references

Search of the Literature for RCTs

Critical Assessment of Method Quality

• 21 Criteria from CONSORT (Consolidation of the

Standards of Reporting Trials, 2001)

• Operationally defined and tested for reliability (intraclass

correlation coefficient for inter-rater reliability was 0.85)

• Applied to each TMD RCT

• Quantitative and qualitative review

Reference- Fricton JR, Ouyang W, Nixdorf DR, Schiffman EL, Velly AM, Look JO. Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders. J Orofac Pain. 2010 Spring;24(2):139-51.

TMD Treatments ReviewedSplints and occlusaltreatments (55 RCTs)*

Stabilization (hard and soft), repositioning and anterior splints, occlusal adjustment, restorative dentistry, and functional orthodontic splints

Physical medicine and exercise (45 RCTs)

PT modalities, stretching, posture, conditioning

Therapeutic Injections and acupuncture (39 RCTs)

Trigger point injections, Botox injections, TMJ joint injections, acupuncture

Psychological therapies (24 RCTs)

Cognitive-behavioral treatment, Biofeedback, Relaxation

Pharmacologic therapy (44 RCTs)

NSAIDS, tricyclics, SSRIs, muscle relaxants, and opioids

TMJ surgery (7 RCTs) TMJ arthroscopic and arthroplasty

* Fricton, J, Look, JO, Wright, E, Alencar, F, Chen, H, Lang, M, Ouyang, W, Velly, AM. Systematic Review of Intraoral Orthopedic Appliance for Temporomandibular Disorders: 51 RCTs Reviewed. J Orofacial Pain 24:237-54.2010.

Splint Therapy

Splints have been suggested to provide protection to muscles and joints and help reduce oral habits

Type of Splint

(7 RCTs: Quality=0.51)

Pain relief compared to placebo?

Hard Stabilization Splints 3 + 3 =

Soft Splints 1 +

No placebo controlled RCTs conducted on repositioning splints,

anterior bite plane, or other splints.

Forest plot from meta-analysis comparing active splints vs placebo splints (n=344)

Results show slight overall trend towards splint

Ekberg et al 1998, 1999

Raphael et al 2001

Ekberg et al 2003

Dao et al 1994

Rubinoff et al 1987

Wassell et al 2004

Conclusion: Stabilization splints are better than placebo when used with more severe TMD patients and while sleeping at night.

Favors placebo Favors splint

Odds ratio and 95% confidence interval

Fricton, J, Look, JO, Wright, E, Alencar, F, Chen, H, Lang, M, Ouyang, W, Velly, AM. Systematic Review of Intraoral Orthopedic Appliance for Temporomandibular Disorders: 51 RCTs Reviewed. J Orofacial Pain 24:237-54.2010.

Stabilization Splint

• Design:Maxillary or mandibular full coverage

• Adjustment: even posterior contact at closure, anterior guidance, and canine guidance or group function in lateral excursions with no balancing side contacts.

• Constructed to guided jaw position and postural rest position (reclined and sitting)

• Better result if it is combined other treatment modalities (self care, exercise, behavioral therapy)

• Works best in patients with high levels of pain but can be used with all levels of severity

Take Home:Stabilization Splint

• Can treat muscle, joint pain, and headache

• Effective even when used only at night

• Better result if it is combined other treatment modalities (self care, exercise, behavioral therapy)

• Works best in patients with high levels of pain but can be used with all levels of severity

Anterior Bite Plane SplintDesign: A maxillary of mandibular hard splint allowing contact of only one of more anterior teeth. The posterior teeth do not contact.

Other names: NTI® splint, Anterior jig, Luca jig, Hawley with biteplane or anterior deprogrammer.

Suggested Indications:

• Headache and muscle pain

• Eliminate proprioceptive feedback from the posterior teeth

• Reduce oral habits and muscle activity

Author Group N Treatment Duration

Outcome measure Result

Shankland et al., 2001

TTH/ Migraine

43

51

A: Mandibular full-coverage occlusal splint

B: NTI anterior bite splint

8 wks Greater than 85% reduction in migraine.

% reduction in tension headache

% reduction in headache intensity

B > A

B > A

B = A

Magnusson et al., 2004

TMJD 14

14

A: Stabilization splint

B: NTI splint

3 mos

6 mos

Subjective symptoms

Anamnestic index

Subjective symptoms

Global improvement

A>B

A>B

A>B

A>B

Jokstad et al., 2005

TMJD 20

18

A: Stabilization splint

B: NTI splint

3 mos Range of motion

Headache

TMJ pain to palpation

Jaw muscle tenderness

Comfort

A = B

A = B

A = B

A = B

A = B

RCTs comparing anterior bite plane to stabilization splints

Take Home: Anterior Bite Plane

•Good results in treating TMJD and headache

•Efficacy equal to stabilization splint

•Better results if it is used in combination with other

treatment modalities

• It may cause anterior bite changes if worn full time

•Consider stabilization splint first for lower risk

How does occlusion relate to TMD?

1. TMD can cause malocclusion

2. TMD treatment can cause iatrogenic malocclusion

3. Malocclusion can complicate TMD treatment

4. Occlusal treatments can be used to treat TMD and occlusal consequences

Occlusal Consequences of TMD

TMD can lead to malocclusion by changing the position of the mandible relative to the maxilla including:

• Lateral pterygoid spasm

• TMJ degenerative joint disease and disk disorder in some cases

• TMJ hyperplasia or hypoplasia

• Uncontrolled bruxism and tooth wear

Iatrogenic Malocclusion from TMD Treatment

Malocclusion may result unintentionally from some TMD

treatments from changing the position of the teeth or the

mandible relative to the maxilla including;

• Partial coverage splints that intrude teeth and cause

anterior or posterior open bite

• Full time use of anterior repositioning splints that cause

anterior prematurities and posterior open bite

• Occlusal shifts from unstable joints after flat plane splints

or orthodontics can result in open bite or cross bites

Permanent posterior open bite from full time use of partial coverage posterior splint. Open bite due to anterior positioning of jaw and/or impaction of posterior teeth

Partial coverage splints

Malocclusion as a contributing factor in TMD

In some cases, TMD is associated with malocclusion. The most commonly cited occlusal factors include;

• Loss of posterior support

• Unilateral prematurities

• Long slide in centric

• Non working interferences

• Unilateral posterior lingual crossbite

• Anterior open bite

• Most occlusal factors are amplified by oral habits

Occlusal dysharmony is only an associated factor in many cross sectional and longitudinal studies

(NS, P≥.05)(NS, P≥.05)(NS, P≥.05)

Occlusal TherapyOcclusal treatment such as occlusal

adjustment, restorative dentistry and

orthodontics (9 RCTs) has been

suggested to provide occlusal stability

for the muscles and joint and reduce

eccentric forces

Type of Occlusal Treatment



Occlusal Adjustment 1 study + 2 studies =

Restorative Dentistry (On-lays) 1 study +

No RCTs conducted on orthodontics, orthognathic surgery,

full crowns, or other occlusal treatments.

Forest plot from meta-analysis comparing occlusal adjustment vs placebo adjustment for TMD treatment (n=182)

Forssel et al 1986

Tsolka et al 1992

Karppinen et al 1999

Results shows no overall difference between groups

Favors placebo Favors Occlusal Adjustment


Fricton, J. Current Evidence Providing Clarity in Management of Temporomandibular Disorders: A Systematic Review of Randomized Clinical Trials for Intra-oral Appliances and Occlusal Therapies. Journal of Evidence based Dentistry. March issue, Vol 6, issue 1, pp 48-52, 2006

Take Home: Occlusal Treatments

Occlusal adjustment no better than placebo adjustment in treating TMD pain.

Occlusal treatment should be reserved for cases when;

• Occlusion is the complaint i.e. uncomfortable bite after oral habits are treated.

• After restorative, orthodontics, or other occlusaltreatment to ensure occlusion is comfortable and functional

• Aesthetic and functional reasons

What Other TMD Treatments Work?

Splints and occlusaltreatments (55 RCTs)

Stabilization (hard and soft), repositioning and anterior splints, occlusal adjustment, restorative dentistry, and functional orthodontic splints


PT modalities, stretching, posture, isometrics, functional, conditioning



Psychological therapies (24 RCTs)


Pharmacologic therapy (44 RCTs)

NSAIDS, Acetominophen, tricyclics, SSRIs, muscle relaxants, and opioids

TMJ surgery (7 RCTs) TMJ arthroscopic and arthroplasty

Exercises for TMD

Exercises are designed to:

1. improve range of motion

2. Reduce muscle and joint pain

3. Improve muscle relaxation

4. Improve posture and postural habits

5. Improve muscle function

6. Improve muscle strength and conditioning

Therapeutic Exercises

Jaw exercise (13 RCTs) has been found to improve range of motion of muscles and joints, relax muscles, improve posture and encourage healing

Type of Exercise



Stretching exercise 2 + 1 =

Resistance exercise 1 +

Posture training 1 +

Forest plot from meta-analysis comparing exercise vs placebo for TMD treatment (n=150)

Conclusion: Exercise show greater improvement than placebo in treating TMD pain and headache. Stretching and posture exercise should be used in cases of myofascial pain and TMJ pain disorders with limited range of motion.

Results shows exercise over placebo

Favors placebo Favors exercise

Burgess et al. 1988

Dall’ Arancio et al. 1993

Minakuchi et al. 2004

Shata et al. 2000


-Fricton, J, Velly, A. Ouyang W., Look, J. Does exercise therapy improve headache? A systematic review with meta-analysis. Current Pain & Headache Reports 13(6):413-419, 2009.

TMD Treatments Reviewed

Splints (42 RCTs) stabilization and repositioning appliances, hard and soft


PT modalities, stretching, function, posture, conditioning



Behavioral and Psychological therapies (21 RCTs)


Pharmacologic therapy (44 RCTs) NSAIDS, acetominophen, tricyclics, SSRIs, muscle relaxants, benzodiazepines, corticosteroids, glucosamine/ chrondroitin, and opioids

Behavioral and Psychological Treatment for TMD Summary of meta-analysis of 24 RCTs

Treatment Efficacy*

Comments

Relaxation

(11 RCTs)

+++ Moderate consistent benefit for headache and TMJD pain

Cognitive behavioral treatment

(8 RCT)

+++ • Moderate consistent benefit for TMJD pain

• additive effect to biofeedback, relaxation, occlusalappliance and rehabilitation therapies as part of a multi-disciplinary treatment.

Biofeedback

(9 RCT)

+++ • Moderate consistent effect for decreasing headache and TMJD pain.

• similar efficacy to splints, physical therapy, and medical interventions over a 1–3 month,

• long-term maintenance of improvement.

Strength of evidence: +++= > 4 positive RCTs, ++= 2 to 4 positive RCTs+ =1 positive RCT, += conflicting evidence, - = negative RCTs, NA= no RCTs conducted

Cognitive Behavioral Therapy

CBT teaches patients to relax muscles, reduce strain to muscles and joints, help reduce oral habits, and encourage healing

Type of CBT compared to placebo



Relaxation Training (5 RCTs) 4 + 1 =

Biofeedback (3 RCTs) 2 + 1 =

Behavioral training for oral habits

(1 RCTs)

1 +

Forest plot from meta-analysis comparing CBT vs placebo for TMD treatment (n=633)

Conclusion: Cognitive behavioral treatments including oral habit instruction, relaxation, or biofeedback should be considered for TMD patients with self reported day or night oral habits or objective indications of them, anxiety, stress, feeling hurried as contributing factors.

Favors placebo Favors CBT

Bussone et al. 1998

Fichtel et al. 2004

Larsson et al. 2005

Loew et al. 2000

Wahlund et al. 2003


TMD Treatments Reviewed

Splints (42 RCTs)

stabilization and repositioning appliances, hard and soft


PT modalities, stretching, function, posture, conditioning



Psychological therapies (21 RCTs) Cognitive-behavioral treatment, Biofeedback, Relaxation

Pharmacologic therapy (44 RCTs) NSAIDS, acetominophen, tricyclics, SSRIs, muscle relaxants, benzodiazepines, corticosteroids, glucosamine/ chrondroitin, and opioids

Pharmacological Agents for TMJD: meta-analysis of 44 RCTs

Treatment Efficacy* Comments

NSAIDs and acetominophen (13 RCTs)

+++ • Consistent evidence for short-term efficacy of reducing mild to moderate TMJD pain and tension type headache

Tricyclic antidepressants (11 RCTs)

+++ • Consistent evidence for TMJD pain, but their side effects can be a problem.

SSRIs (8 RCTs) + - • weak evidence for use with TMJD or tension type headache

Muscle Relaxants (cyclobenzaprineand tizanadine)

(3 RCTs)

+ • Some evidence supporting use but evidence is lacking for their mechanism of action, their relative efficacy, and their indications

Benzodiazepines (3 RCTs)

+ • modest evidence for a slight effect overall for TMJD pain.

Strength of evidence: +++ = > 4 positive RCTs, ++= 2 to 4 positive RCTs+ =1 positive RCT, +- = conflicting evidence, - = negative RCTs, NA= no RCTs conducted

Pharmacological Agents for TMJD: meta-analysis of 44 RCTs

Treatment Efficacy* Comments

Triptans (2 RCTs) - • insufficient evidence for the use in reducing TMJD pain or tension-type headache.

Glucosamine and chondroitin sulfate (2 RCTs)

+ • more beneficial than placebo for osteoarthritis

• at least equal to ibuprofen in terms of pain reduction

• slower onset for relief than NSAIDs but also fewer side effects

Corticosteroids (0 RCTs)

NA • Strong anti-inflammatory agent but no evidence to make recommendation for the use in TMJD pain

Opioids (2 RCTs) + • strong analgesic for moderate to severe acute pain but have insufficient evidence for the use in chronic TMJD pain or headache

Strength of evidence: +++ = > 4 positive RCTs, ++= 2 to 4 positive RCTs+ =1 positive RCT, += conflicting evidence, - = negative RCTs, NA= no RCTs conducted

Forest plot from meta-analysis comparing NSAIDs vs Acetominophen for TMJD/ headache pain (n=1434)

Conclusion: Plot shows a statistically significant net benefit (P < 0.01) associated with single oral doses of the non-steroidal anti-inflammatories, ibuprofen or ketoprofen, when compared to acetaminophen

Favors Acetominophen Favors NSAID


Schachtel et al., 1996 and Mehlisch et al., 1998

Packman et al. 2000Steiner and Lange 1998

Forest plot from meta-analysis comparing Tricyclicsvs Placebo for TMJD/ headache pain (n=484)

Conclusion: there is an overall trend towards showing favorable effects of the tricyclics compared to placebo (P = 0.368).

Favors Placebo Favors Tricyclic


Bendtsen et al., 1996Gobel et al., 1994Holroyd et al., 2001Langemark et al. 1990Pfaffenrath et al. 1994

Take Home: Medications

• NSAID, tricylics, and muscle relaxants improve muscle, joint pain, and headache

• Can have adverse events if used long term (e.g. GI, rebound pain)

• Better result if used short term and combined other treatment modalities (self care, exercise, behavioral therapy)

• Personal Experience: Clonazepam (0.5mg HS) and cyclobenzaprine (10mg hs) works well in patients with high levels of pain, anxiety, and nocturnal habits

“I feel a lot better since I ran out of those pillsyou gave me.”

Analgesic Abuse Headache

Take Home: The Need for Integrative Care

What treatments have an active therapeutic effect beyond placebo?

• Splints, Exercise, Medication, and Behavioral therapy all have significant effects.

• They have a synergistic effect if used together in a multi-modal approach to treatment

• Thus, use a team with complex patients

• Establish a problem list and treatment plan upfront

Development of the Informatics Platform for

Practice‐Based Networks

• A secure web‐based integrated research information system

(IRIS) that integrates investigators, staff, subjects, and providers

to conduct practice‐based research

• Sponsored by NIH/NINR RC2‐011942‐01, Jacko PI and

NIH/NIDCR N01‐22635, Fricton PI

• Used by associations and provider groups to better understand

their clinical practices, their patients, and to extend their care

into the patients life.

Network Portals

Public Portal

Subject Portal Practitioner Portal

Investigator Portal

• New approach to healthcare

• Health providers are informed by each person's unique clinical, genetic, and personal characteristics

• Allows individualized care based on these factors

• Predict susceptibility and course of disease, improve treatment outcomes, and reduce adverse events

A New Book for Patients. Available at Amazon, Barnes&

Nobles, Goodreads, others.

g{tÇ~ çÉâ

break out 1 a systematic reviews fric ton

Documents