Guided Tissue Regeneration in Healing of Through and Through Periapical Lesion

Periapical Lesion Clinical Trial

Official title:

Healing Following Use Of Injectable Platelet Rich Fibrin With Collagen During Surgery In Through And Through Periapical Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391725
• Other study ID #: Arpitha CM
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: April 11, 2021

Study information

• Verified date: December 2019
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 11, 2021
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Lesion

Intervention

Procedure:
• Periapical surgery with guided tissue regeneration
periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules
• Periapical surgery without anyguided tissue regeneration
periapical surgery will be done followed by flap closure

Locations

Country	Name	City	State
India	Sanjay Tewari	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 from baseline in periapical radiolucency at 12 months	2 blinded caliberated operators will score the periapical radiolucency at baseline and 12 month with following scoring scores for 2D healing Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure); scores for 3D healing Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing	baseline to 12 months
Secondary	change in Quality of life from baseline to 7 days	caliberated operator will score the quality of life questionnaire in patients following surgical endodontic treatment	postoperative Day 1 to day 7