MedTrace Logo

Evaluation of Anterior Repositioning Guided Splint Combined With or Without I Platelet-rich Fibrin

NCT06132802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-15

No results posted yet for this study

Summary

The study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of I-PRF with wearing ARS in comparison to arthrocentesis and ARS only.

Conditions

  • Temporomandibular Joint Disorders

Interventions

PROCEDURE

Patients who received treatment involving ARS and arthrocentesis only

A 5mm acrylic anterior repositioning splint (ARS) with maxillary coverage was crafted from alginate impressions. After arthrocentesis, the ARS was worn incrementally over six months, starting at two hours and reaching 14 hours daily. In the second week, wear time was continuous, increasing to 24 hours daily (excluding meals) until the sixth month. The ramp was removed in the seventh week. Follow-ups involved grinding the splint by 1mm every four weeks. Arthrocentesis included anesthesia, betadine prep, and using two 18-gauge needles to inject Ringer's lactate solution (100-200 cc) for joint lavage, freeing the disc by moving the lower jaw in various orientations.

PROCEDURE

Patients who received treatment involving ARS, arthrocentesis, and an I-PRF injection

A 5mm acrylic anterior repositioning splint (ARS) was crafted from alginate impressions, secured with Adam's clasps on upper first molars. After arthrocentesis, patients wore the splint incrementally over six months, starting at two hours and reaching 24 hours daily (excluding meals). The ramp was removed in the seventh week, and follow-ups included grinding the splint by 1mm every four weeks until it reached 3mm, guided by articulating paper. Arthrocentesis involved administering anesthesia, prepping the area with betadine, and using two 18-gauge needles to inject 2-3 ml of Ringer's lactate solution for joint lavage. The lower jaw was moved to free the disc and release fibrous tissue. I-PRF preparation included centrifuging collected blood for 3 minutes at 700 rpm, and the resulting I-PRF was injected into the superior joint space of the lavaged joints.

Sponsors & Collaborators

  • Mahmoud Mohammed Mahmoud Nasef

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-02
Primary Completion
2022-10-14
Completion
2022-10-14

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06132802 on ClinicalTrials.gov