Clinical Trials Directory

Trials / Unknown

UnknownNCT02960048

Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .

Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint in Patients With Temporomandibular Joint Anterior Disc Displacement With Reduction . ( Randomized Controlled Clinical Study)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

Detailed description

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction. PICO: Population (P): Patients with symptomatic anterior disc displacement with reduction. Intervention (I): Michigan splint. Comparator (C): Anterior repositioning splint (ARS) . Outcome(O): Primary 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. Secondary 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. 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.

Conditions

Interventions

TypeNameDescription
DEVICEStabilizing splintA 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks. This area will create the eccentric guidance.
DEVICEAnterior repositioning splintA 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe.

Timeline

Start date
2016-11-01
Primary completion
2017-06-01
Completion
2017-07-01
First posted
2016-11-09
Last updated
2016-11-09

Source: ClinicalTrials.gov record NCT02960048. Inclusion in this directory is not an endorsement.