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

Chronic Apical Periodontitis Clinical Trial

Official title:

A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04389346
• Other study ID #: Ankita Ramani
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 2021

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: DR PANKAJ SANGWAN
• Phone: 9996112202
• Email: drps_1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Periapical surgery using autologous platelet aggregate
PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
• Periapical surgery without autologous platelet aggregate
Flap will be repositioned following apicoectomy directly without placing any platelet aggregate

Locations

Country	Name	City	State
India	Ankita Ramani	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in periapical radiolucency	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	Baseline to 12 Months
Secondary	Clinical success	Clinical success will be assessed by absence of clinical signs and symptoms such as pain, swelling , sinus or tenderness on palpation or percussion	Baseline to 12 Months