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Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects

Evaluate the Effect of Graft and Membrane on Healing of Apicomarginal Defects: A Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04366700
Enrollment
30
Registered
2020-04-29
Start date
2018-11-01
Completion date
2020-09-30
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apicomarginal Defects

Keywords

apicomarginal defects, autograft, prf, collagen membrane

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPeriapical surgery with autograft and 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

PROCEDUREPeriapical surgery with collagen membrane

periapical surgery will be done and the defects will be filled with blood clot and covered with a collagen membrane

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

double

Eligibility

Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with age 16 years to 55 years * Periapical defects with periodontal communication. * Apicomarginal defects with probing depth \> 6mm on mid-buccal and interproximal surfaces

Exclusion criteria

* Presence of buccal bone on flap elevation. * Fractured /perforated roots. * smokers. * pregnant females and lactating mothers

Design outcomes

Primary

MeasureTime frameDescription
change from baseline in periapical radiolucency at 12 monthsBaseline to 12 months2 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

Secondary

MeasureTime frameDescription
Clinical successBaseline to 12 monthsClinical success will be assessed by absence of clinical signs and symptoms

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026