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

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04389346
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Apical Periodontitis	Procedure: Periapical surgery using autologous platelet aggregate; Procedure: Periapical surgery without autologous platelet aggregate	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double
• Primary Purpose: Treatment
• Official Title: A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
• Actual Study Start Date: Jul 1, 2019
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Periapical surgery with PRF group Autologous platelet aggregate (PRF) will be placed over the denuded root surface, following apicoectomy and before flap repositioning.	Procedure: Periapical surgery using autologous platelet aggregate; PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
Placebo Comparator: Control group without PRF Flap will be repositioned following apicoectomy without placement of any autologous platelet aggregate.	Procedure: Periapical surgery without autologous platelet aggregate; Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankita Ramani	Rohtak	Haryana	India	124001

Sponsors and Collaborators

• Postgraduate Institute of Dental Sciences Rohtak

Investigators

• Principal Investigator: ANKITA RAMANI, POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Postgraduate Institute of Dental Sciences Rohtak
• ClinicalTrials.gov Identifier: NCT04389346
• Other Study ID Numbers: Ankita Ramani
• First Posted: May 15, 2020
• Last Update Posted: May 19, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Postgraduate Institute of Dental Sciences Rohtak: Apicomarginal defects; Cone Beam Computed Tomography; Autologous platelet aggregate
• Additional relevant MeSH terms: Periodontitis; Periapical Periodontitis

Study Results

No Results Posted as of May 19, 2020