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Platelet Rich Plasma in Healing of Through and Through Periradicular Lesions

NCT03430557 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-13

No results posted yet for this study

Summary

Title : Evaluation of the efficacy of Platelet Rich Plasma (PRP) in healing of through and through lesions

Rationale: Bone replacement analogues have been used in the healing after periapical surgery. It has been a controversial issue to use bone grafts due to varied outcomes of different studies showing both improved outcomes and no difference. Lacunae while using bone grafts is their radiopacity which compounds the radiographic incomplete or uncertain healing. Thence we will be using platelet rich plasma as bone filling material.

Aims and Objectives : To evaluate outcome of platelet rich plasma in healing after periapical surgery for through an through lesions.

Setting: Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana.

Study Design: Randomized controlled trial

Time frame: 12-18 months

Population/participant : Patients of age 16-45 years (male/female) will be enrolled in the study with diagnosis of through and through lesions.

Inclusion criteria:- Patients of age 16 -45 years, -ve response to sensibility test, failed previous rct with purulent discharge, recurrent episode of purulent discharge.

Exclusion Criteria:- Unrestorable tooth, fractured /perforated roots, serious medical illness, smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for antibiotic prophylaxis prior to dental care.

Sample size - a sample size of 30 patients has been calculated with n=15 in each group.

Methods- Clinically and radiographically diagnosis of lesion, sensibility test by heat, cold, EPT, preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal position \& pocket depth. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by following standardized treatment methods.

Outcome Measures- The primary outcome variables observed for the study will be 3,6,9,12 months clinical and radiographic success rates in terms of resolution of periapical radiolucency using the same criteria as preoperatively on the radiograph and alleviation of clinical sign and symptoms.

Statistical Analysis : Intergroup and intra group comparison will be done according to distribution of data. Categorical data will be analyzed using chi-square test. Regression analysis will be done to observe any association between dependent and independent variables.

Conditions

  • Periapical Lesions

Interventions

PROCEDURE

PRP

platelet rich plasma

PROCEDURE

periapical surgery without PRP

retrograde MTA filling will be done after apicectomy and flap will be closed without filling anything in the bony lesion.

Sponsors & Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2018-03-31
Completion
2018-03-31

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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 NCT03430557 on ClinicalTrials.gov