An interventional study of Periapical surgery with autograft and collagen membrane and Periapical surgery with collagen membrane in Apicomarginal Defects, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
This study will compare the effect of guided tissue regeneration using a mixture of autograft and PRF covered with a collagen membrane as compared to the membrane alone in the healing of apicomarginal defects. Healing of the lesions will be compared 2 dimensionaly and 3 dimensionaly using CBCT.
Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups -in test group 1 -the defects will be filled with a mixture of autograft(which will be obtained from the surrounding buccal cortical plate by using a trephine bur) and prf(will be prepared by Choukron's method) and the defects and denuded root surface will be covered with a collagen membrane and in test group 2 -the defects will be filled with a blood clot and over that the collagen membrane will be placed. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) and will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.. The criteria for a successful outcome included the absence of clinical signs and/or symptoms and radiographic evidence of complete or incomplete healing.
Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.
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Exclusion criteria
periapical surgery will be done and defect will be filled with a mixture of autograft and prf and over the defect and denuded root surface collagen membrane will be placed before closure of flap
Procedure: Periapical surgery with autograft and collagen membrane
periapical surgery will be done and defect will be filled with blood clot and over the defect and denuded root surface collagen membrane will be placed before closure of flap
Procedure: Periapical surgery with collagen membrane
periapical surgery will be done and the defects will be filled with a mixture of autograft and prf and will be covered with a collagen membrane
periapical surgery will be done and the defects will be filled with blood clot and covered with a collagen membrane
change from baseline in periapical radiolucency at 12 months
2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 months by following scoring scores for 2D healing Score1-Complete healing defined by re-establishment of the lamina dura Score 2- Incomplete healing (scar tissue) Score 3- Uncertain healing Score 4- Unsatisfactory healing scores for 3D healing Score1- Complete healing Score 2- Limited healing Score 3- Uncertain healing Score 4- Unsatisfactory healing
Time frame: Baseline to 12 months
Clinical success
Clinical success will be assessed by absence of clinical signs and symptoms
Time frame: Baseline to 12 months
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Postgraduate Institute of Dental Sciences Rohtak