Guided Tissue Regeneration in the Healing of Through and Through Lesions

NCT03284736 | Unknown DMC

• 1 other identifier: pragnesh endo
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in periapical radiolucency by radiograph 1. Complete healing, 2. Incomplete healing 3. Uncertain healing 4. Unsatisfactory healing

  Healing of the lesion will be checked at 3 months interval up to 1 year with the help of software CDR DICOM. At the end of 1 year this reduction in the pathology of lesion will be categorized as complete, incomplete, uncertain, unsatisfactory. Clinical and radiographic examinations will be performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP will not measured until 12 months. Radiographic evaluations Jig radiographs will be taken at 3, 6 and 12th month of follow up.

  Baseline to 1 year

Secondary Outcomes (2)

• Clinical attachment level

  Baseline to 1 year

• Probing depth

  Baseline to 1 year

Study Arms (2)

Periapical surgery with membrane

EXPERIMENTAL

After retrofilling of teeth with MTA , defect was covered with collagen resorbable membrane. healiguide collagen type 1 resorbable membrane covering the defect by extending 2-3 mm in every direction.

Procedure: Resorbable membrane

Periapical surgery without membrane.

ACTIVE COMPARATOR

After retrofilling of teeth with MTA, flap was closed without application of collagen resorbable membrane.

Procedure: periapical surgery without membrane

Interventions

Resorbable membrane PROCEDURE

Also known as: Healiguide collagen type 1 resorbable membrane

Periapical surgery with membrane

periapical surgery without membrane PROCEDURE

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.

Periapical surgery without membrane.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 16 years and above with a clinical \& radiographic diagnosis of through and through periradicular lesion.
• Negative response to vitality test with radiographic evidence of periapical rediolucencies.
• Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
• Failed previous surgery with persistent bony lesion.
• Recurrent episode of purulent discharge and adequate final restoration with no clinical evidence of coronal leakage.

You may not qualify if:

• Unrestorable tooth
• Fractured /perforated roots
• Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis)
• Smokers
• Pregnant females and lactating mothers
• Grade 3 mobile teeth
• The need for antibiotic prophylaxis prior to dental care

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participant and primary investigator are blinded in the study until whole surgical procedure is completed and before suturing the flap.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total number of 15 patients in each group were selected. Patients were randomly allocated by computer program into two group. Clinical and radiographic examinations were performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP were measured until 12 months. Routine examination procedure were used to evaluate any evidence of signs and/or symptoms. Jig radiographs were taken at 3, 6 and 12th month of follow up. Inter and intra observation of data will be analyzed by distribution of data. Categorical data will be analyzed by chi square test. Regression analysis will be done to observe any association between independent and dependent variables. Interobserver/intraobserver reliability with cohen kappa analysis.

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 15, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share