Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication Using CBCT

NCT ID: NCT03905590

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-05-31

Brief Summary

Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT

Detailed Description

Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of periapical defects with periodontal communication: A randomized controlled trial with 3D analysis using CBCT.

Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory. Various studies and case reports have reported high success rate with the use of guided tissue regeneration technique. Only few clinical trials have evaluated the effect of guided tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only two studies have conducted randomized controlled trial. However, no study has used CBCT for the assessment of healing in such type of lesions. So, this is the first randomized controlled trial studying the effect of guided tissue regeneration in the healing of periapical defects with periodontal communication using 3D radiological evaluation using CBCT.

Aim & Objectives: - 1. To evaluate the difference in the healing outcome of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique 2. To evaluate the difference in the healing outcome derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.

Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.

Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population / Participants: - Patients of age 16 years (male/female) and above will be enrolled in the study.

Inclusion criteria: - Patients of age 16 years and above, Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's, periapical defect with periodontal communication, periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root ., -ve response to vitality test, failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.

Exclusion criteria: -Presence of buccal bone on flap elevation, Unrestorable tooth, fractured /perforated roots, smokers, pregnant females and lactating mothers.

Sample size: - 30 patients (15 patients in each group) Methods: - Diagnosis of the lesion will be made clinically and radiographically, vitality will be checked by EPT, preoperative clinical evaluation will include, clinical attachment level, gingival marginal position and pocket depth. Marginal bone loss, width of bony crypt, height of the bony crypt, depth of the crypt and height of the buccal bone plate (if present) will be measured radiographically and at the time of surgery. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by the standardized treatment methods.

Outcome measures: - Follow up of patients will be carried out at 3, 6, 9 & 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.

Statistical method: - The data will be entered into Microsoft Excel and analysed using SPSS (Statistical Package for Social Science) package for relevant statistical comparison. Distribution of data into normal and non-normal will be done by Kolmogorov-Smir-Nov test. If the data will be normal then student T test and paired T test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.

If the data will be non-normal then Mann - Whitney and Wilcoxon rank sum test will be applied for unpaired and paired data respectively. For categorical data Chi - square test will be applied. The interobserver analysis will be done by cohen kappa analysis.

Conditions

Apico Marginal Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

periapical surgery with amniotic membrane

periapical surgery will be done and amniotic membrane will be placed over the defect before closure of flap

Group Type: EXPERIMENTAL

Periapical surgery with amniotic membrane

Intervention Type: PROCEDURE

periapical surgery will be done followed by amniotic membrane placement over the defect

periapical surgery without amniotic membrane

periapical surgery will be done without the placement of amniotic membrane over the defect before closure of flap

Group Type: ACTIVE_COMPARATOR

periapical surgery without amniotic membrane

Intervention Type: PROCEDURE

periapical surgery will be done without placement of membrane over the defect.

Interventions

Periapical surgery with amniotic membrane

periapical surgery will be done followed by amniotic membrane placement over the defect

Intervention Type: PROCEDURE

periapical surgery without amniotic membrane

periapical surgery will be done without placement of membrane over the defect.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients of age 16 years and above.

2. Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.

3. periapical defect with periodontal communication.

4. Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.

5. Negative response to vitality test.

6. failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.

Exclusion Criteria

1. Presence of buccal bone on flap elevation.

2. Unrestorable tooth.

3. fractured /perforated roots.

4. smokers.

5. pregnant females and lactating mothers

.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Post Graduate Institute of Dental Science

Rohtak, Haryana, India

Countries

India

Other Identifiers

RITIKA YADAV

Identifier Type: -

Identifier Source: org_study_id