Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction.

NCT ID: NCT05983653

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-04-01

Brief Summary

This study is aiming To evaluate the treatment effect (anti-inflammatory and healing ) of PRP with arthrocentesis versus arthrocentesis alone on the management of anterior disc displacement with reduction

Detailed Description

The main aim is to determine whether arthrocentesis with and without PRP will affect the treatment outcome of arthrocentesis , in relation to pain , mouth opening, and disc position . PICO

(P): population : patient with TMD and have clinical signs of disc displacement (I): Intervention: arthrocentesis with normal saline (C): Comparison: two groups 150 ml of normal saline lavage and 150 ml arthrocentesis with PRP (O):Outcome :

Interventions: All patients involved in this study will be divided in to two different groups, one group will receive arthrocentesis with PRP and other group received arthrocentesis only

A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations. A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest and MRI to evaluate disc position

Intra operative procedures for 2 groups:

This clinical report describes 2 different manipulations of arthrocentesis with or without PRP

• In two group: infiltration of plain anesthesia was administered using mepivacaine HCl (3%) to anaesthetizing the auriculotemporal nerve followed by subcutaneous at side of needle insertion. Injection to control pain . Scrubbing and draping of the patient was carried out in a standard fashion using betadine surgical scrub.

A straight line is drawn from the medial portion of the ear tragus to the lateral corner of the eye. In this line, two needle insertion points are marked. The first, more posterior point will be at a distance of 10 mm from the tragus and 2 mm below the canthus tragus line. This is the approximate area of the maximum concavity of the glenoid fossa. The distance is about 25mm from skin to the centre of the joint space .The second point will be 20 mm in front of tragus and 10 mm below this same line.

This marking indicates the site of the eminence of the TMJ. After the points of insertion for the two needles have been marked, local anaesthetic is injected at the planned entrance points. Two 19 gauge needles are inserted in the anterior and posterior recesses of the upper joint space . Through one needle, normal saline 200 ml is injected into the superior joint space. The second needle acts as an outflow portal, which allows lavage of the joint cavity

• in the control group:
• in the 1 st study group: The lavage will be 150 ml of normal saline
• in the 2 nd study group: The lavage will be 150 ml of normal saline +PRP

Follow up Patients will be evaluated at day of arthrocentesis and weekly there after for the first month and then after 6 month. clinical assessment will be achieved postoperatively to calculate and assessment of maximum mouth opening , pain and disc position.

Recruitment:

1. Patients' data will be enrolled in database of the Outpatient clinics of the Department of Oral & maxillofacial surgery, Faculty of Dentistry, Cairo University

2. If there is a potential eligibility, the patient will be examined thoroughly as described before.

3. Consecutive sampling is done through screening of patients. This will continue until the target population is achieved.

4. Identifying and recruiting potential subjects is achieved through patient database Assignment of interventions

Allocation:

1. Randomization:

assistant supervisor will carry out the randomization process using a software www.rand.org with a ratio of 1:1.

2. Allocation concealment mechanism:

All patients who give consent for participation and who fulfill the inclusion criteria will be randomized. Funded patient files in a dark sealed envelope will be the method for allocation concealment.

3. Implementation The supervisors are responsible of division the sealed envelopes into four groups and implementation for patients allocation. Enrolling and helping participants to interventions will by researcher

Masking/blinding:

Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, evaluators and statistician will be blinded.

Data collection, management, and analysis:

Data collection methods Primary Outcome: The researcher and assistant supervisor. will calculate and assessment of mouth opening , pain and jaw movement for TWO groups.

Plans to promote participant retention and complete follow- up:

Participant Retention:

A periodic regular follow up recalls will be planned .

Participant Withdrawal:

The patient is allowed to drop at any time from the study Participant withdrawal will be recorded and the patient will be excluded from the study. A percentage in the sample size is calculated to make up for any losses. The investigator also may withdraw participants from the study under strict certain conditions and only if the proposed therapy were considered harmful to the patient.

Data management:

Data forms and data entry

All these procedures will be done by Supervisor :

All data will be entered electronically. Patient files are to be stored in numerical order and stored in secure and accessible place. All data will be maintained in storage for 1 year after completion of the study.

The electronic data and the scans of the patient will be backed up on a Drop box file for ensuring back up and ease of accessibility. Data Transmission and editing The assessor data entry will be transmitted from the assessors to database officer in the blind separate datasheets who in return record them in participant chart before sending them to the statistician. Security and Back-up of data All forms of the procedures related to study data will be kept in the project secure folder. Access to the study data will be restricted only to database officer. A complete back up of the primary database will be performed twice a month. Back-ups of periodic data analysis file will be kept.

Statistical methods:

Data will be coded and entered using the statistical package SPSS version 22. Data will be summarized using mean and standard deviation. Data will be explored for normality using kolmogorov smirnov test. Comparisons between two groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by kruskal wallis test. Categorical data will be analyzed using chi square test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed.

Data monitoring:

Monitoring The main supervisor will be responsible for data monitoring to evaluate the outcome measures and any possible side effects that might affect the outcome.

Audit Auditing of the study design will be done by the assistant supervisor

Ethics and dissemination

Research ethics approval This protocol and the template informed consent form will be reviewed by the Ethics Committee of Scientific Research - Faculty of Dentistry - Cairo University

Protocol amendments Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be agreed upon by the Council of oral and maxillofacial surgery department.

Informed consent Researcher M.A will introduce and discuss the trial to patients who will be shown a video regarding the main aspects of the trial. Patients will then be able to have an informed discussion with the participating consultant. Researcher will obtain written consent from patients willing to participate in the trial. All consent forms will be translated into Arabic.

Confidentiality All study-related information such as photos, panoramic x-ray, forms, charts will be stored in a password protected folder on the department database. The password will be available to the study team. But any personal information related to the patient's ID will be stored in and will acquire a coded ID with access only to the database officer.

Declaration of interest The study is self-funded and there is no conflict of interest to declare.

Access to data All the research team will have access to the data sets. All data sets will be password protected. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information and the participant will be only identified by patient number.

Post-trial care All patients will have the primary research contact number in case there is any emergency. Follow up will continue until all patients are satisfied.

Dissemination policy Study results will be published as partial fulfillment of the requirements for master's degree in Oral and maxillofacial surgery. Topics suggested for presentation or publication will be circulated to the authors

Conditions

TMJ Disc Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

150 ml of normal saline lavage

in the first arm, 150 ml of normal saline lavage alone without PRP

Group Type: ACTIVE_COMPARATOR

arthrocentesis without PRP

Intervention Type: PROCEDURE

150 ml arthrocentesis without PRP

150 ml arthrocentesis with PRP

in the second arm, 150 ml of normal saline arthrocentesis with PRP

Group Type: ACTIVE_COMPARATOR

arthrocentesis with PRP

Intervention Type: PROCEDURE

150 ml arthrocentesis with PRP

Interventions

arthrocentesis without PRP

150 ml arthrocentesis without PRP

Intervention Type: PROCEDURE

arthrocentesis with PRP

150 ml arthrocentesis with PRP

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

Patients were excluded from the study if they had previous TMJ surgery, a medical history of any systematic disease, and patients participating in other studies.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Ibraheem Mahmoud Alhoor

Principal Investigator ,master degree candidiate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmine AA Nassar

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of dentistry Cairo Universty

Cairo, Manial, Egypt

Countries

Egypt

References

Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.

Reference Type: BACKGROUND

PMID: 36523721 (View on PubMed)

Other Identifiers

arthrocentesis and PRP on TMJ

Identifier Type: -

Identifier Source: org_study_id