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UnknownNCT05171543

Effect of Combined Use of an Allograft and Membrane on the Healing Outcome of Apicomarginal Defects

Effect of Combined Use of an Allograft and a Membrane on the Healing Outcome of Apicomarginal Defects Using 2D and 3D Evaluation

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
Sex
All
Age
16 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Healing of apicomarginal defects using 2 different groups, one being treated with the use of an allograft and a membrane and a control group, will be assessed and compared using 2D and 3D criteria. Also,quality of life will be compared between the two groups.

Detailed description

Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region. Various resorbable and non resorbable collagen membrane with or without xenograft, allograft and alloplastic materials have been used in different studies. Although animal studies have reported high success rates with the use of bone graft materials and membranes over the controls but no human study till date has evaluated or compared the effect of using an allograft and membrane versus Control. Thus, the aim of the present study is to investigate to two hypothesis. The first null hypothesis stated that there would be no difference between quality of life and healing outcome of periapical defects with periodontal communications following surgery using membrane with allograft and the conventional control group utilizing no GTR technique. The second null hypothesis stated that there would be no difference in outcome derived from the assessment of 2D periapical radiographs and 3D CBCT imaging.

Conditions

Interventions

TypeNameDescription
PROCEDUREPeriapical surgery with placement of an allograft and a membranePeriapical surgery will be done followed by placement of an allograft into the defect and a membrane over the defect before closure of the flap.

Timeline

Start date
2021-02-01
Primary completion
2022-05-01
Completion
2022-05-01
First posted
2021-12-29
Last updated
2021-12-29

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05171543. Inclusion in this directory is not an endorsement.