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Guided Tissue Regeneration in the Healing of Through and Through Lesions

NCT03284736 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-09-15

No results posted yet for this study

Summary

Study Title: Effects of Guided Tissue Regeneration on the Healing of Through \& Through Periradicular Lesions - A Randomized Controlled Study

Rationale: Through and through defects found to be difficult to heal without GTR intervention. Various studies has been done either with graft or without graft but no randomized controlled trial has been done on resorbable membrane(GTR) in through and through lesion.

Aim \& Objectives: To evaluate the effect of resorbable collagen membrane in the healing of through \& through lesion.

Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the department of Conservative Dentistry \& Endodontics.

Study Design: Randomized Controlled Trial

Time Frame: March 2016 to October 2017

Population / Participants: Patients of age 16 years (male/female) and above were enrolled in the study.

Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed previous root canal treatment with purulent discharge, failed previous surgery, 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: 30 patients (15 patients in each group)

Methods: Clinically and radiographically diagnosis of lesion, vitality check by 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: Follow up of patients were carried out at 3, 6, 9 \& 12 months and outcome measures were compared with same method done pre operatively and described as Complete healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing (failure).

Statistical method: Data will be analyzed with suitable statistics method.

Conditions

  • Periapical Lesions

Interventions

PROCEDURE

Resorbable membrane

PROCEDURE

periapical surgery without membrane

after removing pathology and retro-filling the tooth /teeth wit MTA the defect area is left as it is and flap is closed without resorbable membrane.

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-11-30
Completion
2017-11-30

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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 NCT03284736 on ClinicalTrials.gov