A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates

Not Applicable

• Conditions: Chronic Apical Periodontitis

• Registration Number: NCT04389346
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Brief Summary

This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.

Detailed Description

Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. 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) 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.

Study Timeline

• Study Start: 2019-07-01
• Status Verified: 2020-04
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Last Update Submitted: 2020-05-17
• Last Update Posted: 2020-05-19
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
• Apicomarginal communication having probing depth > 6mm.
• Patients with no general medical contraindications for oral surgical procedures.
• Recurrent episodes of purulent discharge.
• Failed previous root canal treatment.
• Failed previous surgery with persistent bony lesion.
• Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria

• Clinical or radiographic evidence of root fracture.
• Resorptive processes involving more than apical third of the root.
• Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy.
• Any condition effecting rate of healing like smoking.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in periapical radiolucency	Baseline to 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

Secondary Outcome Measures

Name	Time	Method
Clinical success	Baseline to 12 Months	Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion

Trial Locations

Locations (1)

Ankita Ramani; 🇮🇳 Rohtak, Haryana, India