Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification

Not Applicable

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Open flap debridement procedure in intrabony defects.; Procedure: Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane; Procedure: Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material

• Registration Number: NCT04195295
• Lead Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Brief Summary

The prospective study is a interventional study to evaluate and compare the effectiveness of periosteal pedicle as grafting technique and egg shell derived nano hydroxyapatite as regenerative graft material for regeneration of intrabony defects.

Detailed Description

30 Patients visiting the outpatient Department of Periodontology Krishnadevaraya College of Dental Sciences and Hospital, Bangalore will be enrolled for 6 month folllow up study based on the inclusion and exclusion criteria. Patients age ranged from 25 to 55 years. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects are included in the study.

The patients are allocated to three goups through computer generated randomisation as:

Group A (n=10) - Egg shell derived nano hydroxyapatite (EnHA) graft and periosteal pedicle as barrier membrane.

Group B (n=10) - Only EnHA as graft. Group C (n=10) - An open flap debridement procedure only.

Study Timeline

• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2019-12-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients within the age group of 25 to 55 years.
2. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects as detected on CBCT.
3. Gingival biotype >1.5mm
4. Systemically healthy subjects.
5. Patients who are compliant.
6. Patients who had not received any periodontal treatment in the last six months.

Exclusion Criteria

1. Pregnant and Lactating females.
2. Aggressive periodontitis.
3. Presence of pulpal or periapical involvement.
4. Patients with known systemic diseases and conditions precluding any elective surgery.
5. Patients who were smokers.
6. Teeth with poor prognosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open flap debridement	Open flap debridement procedure in intrabony defects.	open flap debridement procedure only.
periosteal membrane and egg shell graft	Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane	Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane.
only egg shell graft	Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material	Only Egg shell derived nano hydroxyapatite (EnHA) as graft material.

Primary Outcome Measures

Name	Time	Method
Bone defect fill and density	6 months	bone defect fill and bone density will be measured pre operatively and post operatively using CBCT

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	6 months	probing pocket depth is measured using UNC 15 probe pre operatively and post operatively

Trial Locations

Locations (1)

Krishnadevaraya college of dental sciences; 🇮🇳 Bangalore, Karnataka, India