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Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Unknown

Conditions

Periapical Lesion

Treatments

Procedure: Periapical surgery with guided tissue regeneration
Procedure: Periapical surgery without anyguided tissue regeneration

Study type

Interventional

Funder types

Other

Identifiers

NCT04391725
Arpitha CM

Details and patient eligibility

About

Aim of this study is to evaluate the effect of i-PRF in the healing of through and through periapical lesion after periradicular surgery

Full description

Detailed patient examination will be carried out and those satisfying inclusion criteria will be enrolled in the study. Written informed consent will be obtained and patients will be randomly allocated to two groups. Entire surgical procedure will be carried out by single operator. After complete elevation of the flap, debridement (periradicular curettage -enucleation) of the bony lesion will be performed. 3 mm root-tip resection will be performed and root end cavity will be prepared using an ultrasonic diamond-coated retrotip. Root end filling will be done with mineral trioxide aggregate (MTA). In test group The i-PRF will be produced and incorporated with collagen will be used to fill into the defect. In the control group, no guided tissue regeneration technique will be used. Flap will be re-positioned and sutured using nonabsorbable 4-0 silk sutures.Sutures will be removed 4-7 days postoperatively.

Enrollment

32 estimated patients

Sex

All

Ages

16 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of age 16-55 years with a clinical & radiographic diagnosis of through and through periradicular lesion using CBCT
  • Negative response to sensitivity tests with radiographic evidence of periapical radiolucency.
  • Failed previous root canal treatment primary or secondary with purulent discharge and radiographic evidence of periapical pathology.
  • The teeth must have adequate final restoration with no clinical evidence of coronal leakage.

Exclusion criteria

  • Unrestorable tooth.
  • Fractured / perforated tooth.
  • Systemic diseases contraindicating surgical procedures or with potential to affect healing.
  • Teeth with deep pockets.
  • Patient requiring antibiotic premedication.
  • Patients with history of antibiotic use in last 3 months.
  • Smokers

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups

Periapical surgery with guided tissue regeneration
Experimental group
Description:
Patients with through and through periapical lesion will undergo periapical surgery and the defect is filled with mixture of iPRF and type 1 collagen granules before flap closure.
Treatment:
Procedure: Periapical surgery with guided tissue regeneration
Periapical surgery without any guided tissue regeneration
Active Comparator group
Description:
Patients with through and through periapical lesion will undergo periapical surgery and flap closure done.
Treatment:
Procedure: Periapical surgery without anyguided tissue regeneration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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