Evaluation Lingual Ring Splint

TMJ Disc Disorder Clinical Trial

Official title:

Clinical Evaluation of Lingual Ring Splint For Management Anterior Disc Displacement With Reduction (Pilot Study Clinical Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03000790
• Other study ID #: CairoLRS
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2016
• Last updated: December 21, 2016
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: Ahmed Nassar, BSC
• Phone: 01282533585
• Email: dentgemy1000[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain relief and improvement of mouth opening , lateral excursion and protrusion

Outcome:

• 1ry outcome: 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.

• 2ry outcome:

1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.

2. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws

3. protrusion. The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

Device:
• Lingual Ring Splint
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (7)

Conti PC, Corrêa 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Maximum mouth opening.	measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm	3 months	No
Secondary	Lateral excursion.	measuring the distance between midline of upper and lower jaws . Unit: mm	3 months	No
Secondary	Protrusion.	The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.	3 months	No