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

Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, Derived From Egg Shell Along With Periosteum as Barrier Membrane Under Magnification - An Interventional Study

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.

Study Overview

• Status: Unknown
• Conditions: Intrabony Periodontal Defect
• Intervention / Treatment: 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; Procedure: Open flap debridement procedure in 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Rashmi P, MDS; Phone Number: 9900925844; Email: rashprams2005@yahoo.co.in
• Study Contact Backup: Name: Dr. Sri Vani T. M, MDS; Phone Number: 9406443033; Email: vani.tammina@gmail.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Recruiting
      • Krishnadevaraya college of dental sciences
      • Contact: Rashmi P, MDS; Phone Number: 9900925844; Email: rashparams2005@yahoo.co.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: periosteal membrane and egg shell graft; Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane.	Procedure: Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane; In group A, the full thickness mucoperiosteal flap will be elevated, which will be extended apically to expose sufficient amount of periosteum.; Periosteal membrane will be separated from the full thickness mucoperiosteal flap and released by one vertical incision mesially and one horizontal incision apically.; Posteriorly, the periosteum remained attached with the mucoperiosteal flap, so that blood supply could be maintained in the reflected periosteum.; Then the graft material will be packed into the defect.; Then periosteal membrane will be turned over the intrabony defect in such a way that the defect was completely covered by the periosteal membrane
Experimental: only egg shell graft; Only Egg shell derived nano hydroxyapatite (EnHA) as graft material.	Procedure: Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material; Full thickness mucoperiosteal flap will be raised and Vertical releasing incisions are used if necessary for better access to the surgical site. Then EnHA graft material will be placed into the defect before suturing the mucoperiosteal flap.
Active Comparator: open flap debridement; open flap debridement procedure only.	Procedure: Open flap debridement procedure in intrabony defects.; full thickness mucoperiosteal flap will be raised, entire granulation tissue will be removed from the defects, the pocket epithelium was curetted from the inner surface of the flap, and the roots were thoroughly scaled and planed by means of manual and ultrasonic instruments. Then the operative area will be irrigated with sterile saline. After that, the mucoperiosteal flaps will be sutured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone defect fill and density	bone defect fill and bone density will be measured pre operatively and post operatively using CBCT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	probing pocket depth is measured using UNC 15 probe pre operatively and post operatively	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Principal Investigator: Dr. Rashmi P, MDS, Krishnadevaraya college of dental sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 02_D012_102133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No