Platelet Rich Plasma in Healing of Through and Through Periradicular Lesions

NCT03430557 | Unknown DMC

• 1 other identifier: Ritika
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Title : Evaluation of the efficacy of Platelet Rich Plasma (PRP) in healing of through and through lesions Rationale: Bone replacement analogues have been used in the healing after periapical surgery. It has been a controversial issue to use bone grafts due to varied outcomes of different studies showing both improved outcomes and no difference. Lacunae while using bone grafts is their radiopacity which compounds the radiographic incomplete or uncertain healing. Thence we will be using platelet rich plasma as bone filling material. Aims and Objectives : To evaluate outcome of platelet rich plasma in healing after periapical surgery for through an through lesions. Setting: Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana. Study Design: Randomized controlled trial Time frame: 12-18 months Population/participant : Patients of age 16-45 years (male/female) will be enrolled in the study with diagnosis of through and through lesions. Inclusion criteria:- Patients of age 16 -45 years, -ve response to sensibility test, failed previous rct with purulent discharge, recurrent episode of purulent discharge. Exclusion Criteria:- Unrestorable tooth, fractured /perforated roots, serious medical illness, smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for antibiotic prophylaxis prior to dental care. Sample size - a sample size of 30 patients has been calculated with n=15 in each group. Methods- Clinically and radiographically diagnosis of lesion, sensibility test by heat, cold, EPT, preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal position \& pocket depth. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by following standardized treatment methods. Outcome Measures- The primary outcome variables observed for the study will be 3,6,9,12 months clinical and radiographic success rates in terms of resolution of periapical radiolucency using the same criteria as preoperatively on the radiograph and alleviation of clinical sign and symptoms. Statistical Analysis : Intergroup and intra group comparison will be done according to distribution of data. Categorical data will be analyzed using chi-square test. Regression analysis will be done to observe any association between dependent and independent variables.

Conditions

Periapical Lesions

Keywords

Endodontic surgery

Outcome Measures

Primary Outcomes (1)

• CHANGE IN PERIAPICAL RADIOLUCENCY ON RADIOGRAPH

  Radiographs will be taken at an interval of every 3 months for 1 year with the help of CDR DICOM. The lesion will be categorised as complete healing,incomplete healing,uncertain healing and failure. cllinical and radiographic examination will be performed at 3,6,9 and 12 months on same parameters as baseline except PD,CAL and GMP will not be measured till 12 months

  Baseline to 1 year

Secondary Outcomes (2)

• Clinical attachment level

  Baseline to 1 year

• Probing depth

  Baseline to 1 year

Study Arms (2)

Periapical surgery with PRP

EXPERIMENTAL

MTA Retrograde filling will be performed after apicectomy for involved teeth and PRP will be filled in the lesion before closure of flap

Procedure: PRP

Periapical surgery without PRP

ACTIVE COMPARATOR

MTA Retrograde filling will be performed after apicectomy for involved teeth and flap will be closed without placement of PRP

Procedure: periapical surgery without PRP

Interventions

PRP PROCEDURE

platelet rich plasma

Periapical surgery with PRP

periapical surgery without PRP PROCEDURE

retrograde MTA filling will be done after apicectomy and flap will be closed without filling anything in the bony lesion.

Periapical surgery without PRP

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients of age 16-45 years with a clinical \& radiographic diagnosis of through and through periradicular lesion through CBCT.
• Negative response to sensibility tests with radiographic evidence of periapical radiolucencies.
• Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
• Recurrent episode of purulent discharge and adequate final restoration with no clinical evidence of coronal leakage.

You may not qualify if:

• \. Unrestorable tooth 2. Fractured /perforated roots 3. Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life Threatening conditions or requiring antibiotic prophylaxis) 4. Smokers 5. Pregnant females and lactating mothers 6. Grade 3 mobile teeth

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share