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

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ClinicalTrials.gov Identifier: NCT02329678
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak

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.


Condition or disease Intervention/treatment Phase
Apicomarginal Defects Procedure: Peripical surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Guided Tissue Regeneration Membrane in the Healing of Apicomarginal Defects - A Prospective, Controlled Clinical Trial.
Study Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: collagen membrane group and control group
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
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.

Active Comparator: Control group
Control Group:No membrane was placed after periapical surgery.
Procedure: Peripical surgery
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.




Primary Outcome Measures :
  1. Pocket depth [ Time Frame: baseline to one year ]
  2. Clinical attachment level [ Time Frame: baseline to one year ]
  3. Gingival margin position [ Time Frame: baseline to one year ]
  4. size of apical radiolucency [ Time Frame: baseline to one year ]

Secondary Outcome Measures :
  1. pain swelling sinus tract [ Time Frame: base line to one year ]


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Ages Eligible for Study:   16 Years to 47 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
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Responsible Party: Sanjay Tewari, Professor, Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier: NCT02329678    
Other Study ID Numbers: Pgimsrohtak
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014
Keywords provided by Sanjay Tewari, Postgraduate Institute of Dental Sciences Rohtak:
Apicomarginal defects
clinical study/trial
collagen membrane
guided tissue regeneration
endodontic microsurgery