Efficacy of Guided Tissue Regeneration Membrane in the Healing of Apicomarginal Defects

NCT02329678 | Completed DMC

• 1 other identifier: Pgimsrohtak
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: The present clinical trial was conducted to evaluate the efficacy of membrane barrier in the healing of apicomarginal defects. Methods: Thirty patients meeting inclusion criteria were selected and allocated randomly into two groups: collagen membrane group and control group. Clinical and radiographic measurements were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after surgery. The criteria for success included the absence of clinical signs and symptoms, and complete or incomplete radiographic healing.

Conditions

Apicomarginal Defects

Keywords

Apicomarginal defects; clinical study/trial; collagen membrane; guided tissue regeneration; endodontic microsurgery

Outcome Measures

Primary Outcomes (4)

• Pocket depth

  baseline to one year

• Clinical attachment level

  baseline to one year

• Gingival margin position

  baseline to one year

• size of apical radiolucency

  baseline to one year

Secondary Outcomes (1)

• pain swelling sinus tract

  base line to one year

Study Arms (2)

collagen membrane group and control group

ACTIVE COMPARATOR

GTR group: a bioresorbable collagen membrane (Healiguide, Advanced Biotech Products (P) Ltd., Encoll Corp., Fremont, CA, USA) was placed over the apicomarginal defect, covering 2-3mm of the healthy bone around all the margins after periodical surgery.

Procedure: Peripical surgery

Control group

ACTIVE COMPARATOR

Control Group:No membrane was placed after periapical surgery.

Procedure: Peripical surgery

Interventions

Peripical surgery PROCEDURE

Thirty patients meeting inclusion criteria were selected and allocated randomly into two groups: collagen membrane group and control group. Clinical and radiographic measurements were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after surgery. The criteria for success included the absence of clinical signs and symptoms, and complete or incomplete radiographic healing.

Control group; collagen membrane group and control group

Eligibility Criteria

• Age: 16 Years - 47 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligibility criteria included apicomarginal communication confined to buccal aspect with a pocket depth (PD) of \>6 mm and recurrent episodes of purulent discharge, teeth with negative response to vitality tests, with radiographic evidence of periapical radiolucencies, failed previous root canal treatment or retreatment at least 1 year previously, and adequate final restoration with no clinical evidence of coronal leakage

You may not qualify if:

• Teeth with vertical root fracture, resorptive processes extending to more than the apical third of the root, and subjects with chronic generalized periodontitis, systemic disease contraindicating surgical procedures, and conditions affecting rate of healing like diabetes and smoking were excluded from the study.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: January 1, 2015
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: January 1, 2015

Record last verified: 2014-12