Evaluation Lingual Ring Splint

NCT03000790 | Unknown

• 1 other identifier: CairoLRS
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction

Conditions

TMJ Disc Disorder

Keywords

Anterior disc displacement; TMD therapy; internal derangement; Lingual Ring

Outcome Measures

Primary Outcomes (1)

• Patients' subjective pain experience.

  Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.

  3 months

Secondary Outcomes (3)

• Maximum mouth opening.

  3 months

• Lateral excursion.

  3 months

• Protrusion.

  3 months

Study Arms (1)

Lingual Ring Splint

EXPERIMENTAL

A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed. The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior arch will make the Ring around the tongue

Device: Lingual Ring Splint

Interventions

Lingual Ring Splint DEVICE

A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed. The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior archwill make the Ring around the tongue

Lingual Ring Splint

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient from 15 to 50 years old.
• Report of pain in preauricular region, in the last 30 days, worsened by functional activities, such as chewing and talking.
• Presence of disc displacement with reduction, arthralgia and joint clicking that occurred at both middle to late opening and late closing (near maximum cuspation) and pain in the TMJ area aggravated by jaw movement and function.
• positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

You may not qualify if:

• Individuals with a recent history of trauma in the face and/or neck area.
• Individuals with systemic diseases that can affect TMJ.
• History of TMJ surgery.
• Individuals with dental pain.
• Individuals with myofascial pain, disc displacement with reduction or osteoarthritis.
• Individuals under dental or TMD management.
• Individuals wearing full or partial dentures.
• Individuals with major psychological disorders.
• Nonreducing dislocations of the articular disk in the acute form of TMD
• Consequences of condoyle fractures and/or fracture of another maxillofacial zone.
• In therapy for the same pathologies.
• Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
• Well-known pathologies of neurologic and/or psychic nature and other forms of migraine.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• Srivastava R, Jyoti B, Devi P. Oral splint for temporomandibular joint disorders with revolutionary fluid system. Dent Res J (Isfahan). 2013 May;10(3):307-13.

  PMID: 24019797 BACKGROUND

• Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25.

  PMID: 26644756 BACKGROUND

• Conti PC, Correa AS, Lauris JR, Stuginski-Barbosa J. Management of painful temporomandibular joint clicking with different intraoral devices and counseling: a controlled study. J Appl Oral Sci. 2015 Oct;23(5):529-35. doi: 10.1590/1678-775720140438. Epub 2015 Jul 21.

  PMID: 26200526 BACKGROUND

• Lee HS, Baek HS, Song DS, Kim HC, Kim HG, Kim BJ, Kim MS, Shin SH, Jung SH, Kim CH. Effect of simultaneous therapy of arthrocentesis and occlusal splints on temporomandibular disorders: anterior disc displacement without reduction. J Korean Assoc Oral Maxillofac Surg. 2013 Feb;39(1):14-20. doi: 10.5125/jkaoms.2013.39.1.14. Epub 2013 Feb 21.

  PMID: 24471012 BACKGROUND

• Liu J, Mu H, Wang Z, Lan J, Zhang S, Long X, Zhang D. Joint cavity injection combined with manual reduction and stabilization splint treatment of anterior disc displacement. Int J Clin Exp Med. 2015 Apr 15;8(4):5943-8. eCollection 2015.

  PMID: 26131189 BACKGROUND

• Muhtarogullari M, Avci M, Yuzugullu B. Efficiency of pivot splints as jaw exercise apparatus in combination with stabilization splints in anterior disc displacement without reduction: a retrospective study. Head Face Med. 2014 Oct 9;10:42. doi: 10.1186/1746-160X-10-42.

  PMID: 25300939 BACKGROUND

• Rampello A, Falisi G, Panti F, DI Paolo C. A new aid in TMD Therapy: the Universal Neuromuscular Immediate Relaxing appliance "UNIRA". Oral Implantol (Rome). 2010 Jan;3(1):20-32. Epub 2010 Nov 19.

  PMID: 23285377 BACKGROUND

Study Officials

• Nadia Galal, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Nassar, BSC

CONTACT

01282533585; dentgemy1000@gmail.com

Ahmed El-Sharkawy, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist at ministry of health

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 22, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 22, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share