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

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown

Conditions

Chronic Apical Periodontitis

Treatments

Procedure: Periapical surgery using autologous platelet aggregate
Procedure: Periapical surgery without autologous platelet aggregate

Study type

Interventional

Funder types

Other

Identifiers

NCT04389346
Ankita Ramani

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Central trial contact

DR PANKAJ SANGWAN; ANKITA RAMANI

Data sourced from clinicaltrials.gov

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