## Protocol Section
### Identification Module
**NCT ID:** NCT02992379

**Brief Title:** Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint

**Official Title:** Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint as Treatment for TMJ Anterior Disc Displacement Without Reduction

#### Organization Study ID Info
**ID:** cairo ss-ps
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2016-12-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-12

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2016-12-14
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-29
**Study First Submit QC Date:** 2016-12-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Hesham Mohamed mohamed elsayed safa

**Investigator Title:** Resident at National Cancer Institute

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction

**Detailed Description:** To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction

PICO:

Population (P): Patients with symptomatic anterior disc displacement without reduction.

Intervention (I): pivot splint.

Comparator (C): stabilizing 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 Module

**Conditions:**

- TMJ Disc Disorder

**Keywords:**

- Anterior disc displacement

- Stabilizing splint

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Active Comparator: stabilizing splint A 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. intervention: pivot splint

**Intervention Names:**

- Device: pivot splint

- Device: stabilizing splint

**Label:** stabilizing splint

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Experimental: pivot splint A 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.

Other Names: PS

**Intervention Names:**

- Device: pivot splint

- Device: stabilizing splint

**Label:** pivot splint

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- pivot splint

- stabilizing splint

**Description:** A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of selfcuring 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.

**Name:** pivot splint

**Other Names:**

- PS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- pivot splint

- stabilizing splint

**Description:** A 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. intervention: pivot splint

**Name:** stabilizing splint

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Patients' subjective pain experience (numerical rating scale)

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** measuring the distance between the incisal edges of the upper and lower central incisors using a ruler. Unit: mm

**Measure:** Maximum mouth opening (Unit: mm)

**Time Frame:** 6 months

**Description:** measuring the distance between midline of upper and lower jaws. Unit: mm

**Measure:** Lateral excursion (Unit: mm)

**Time Frame:** 6 months

**Description:** 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.

**Measure:** Protrusion (distance in mm)

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patient from 15 to 50 years old
* Report of pain in preauricular region worsened by functional activities, such as chewing and talking
* Presence of disc displacement with reduction and joint clicking
* Positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI)

Exclusion Criteria:

* Individuals with systemic diseases that can affect TMJ
* History of TMJ surgery
* Individuals with osteoarthritis
* Individuals under TMD management
* Individuals wearing full or partial dentures
* Reducing dislocations of the articular disc
* Consequences of condyle 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)
* Individuals with a recent history of trauma in the face and/or neck area

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Dr.hesham_dent@hotmail.com

**Name:** hesham M safa, master

**Phone:** 01001720677

**Role:** CONTACT

**Contact 2:**

**Email:** omniya.abdelaziz@gmail.com

**Name:** Omniya Abdelaziz, lecturer

**Phone:** 01001203583

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Nadia Galal, Ass.prof

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Ebrahim S, Montoya L, Busse JW, Carrasco-Labra A, Guyatt GH; Medically Unexplained Syndromes Research Group. The effectiveness of splint therapy in patients with temporomandibular disorders: a systematic review and meta-analysis. J Am Dent Assoc. 2012 Aug;143(8):847-57. doi: 10.14219/jada.archive.2012.0289.

**PMID:** 22855899

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
