Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedStudy Start
First participant enrolled
December 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedAugust 12, 2020
August 1, 2020
1.9 years
December 6, 2019
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Bone defect fill and density
bone defect fill and bone density will be measured pre operatively and post operatively using CBCT
6 months
Secondary Outcomes (1)
Probing pocket depth
6 months
Study Arms (3)
periosteal membrane and egg shell graft
EXPERIMENTALEgg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane.
only egg shell graft
EXPERIMENTALOnly Egg shell derived nano hydroxyapatite (EnHA) as graft material.
open flap debridement
ACTIVE COMPARATORopen flap debridement procedure only.
Interventions
* 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
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.
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.
Eligibility Criteria
You may qualify if:
- Patients within the age group of 25 to 55 years.
- Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects as detected on CBCT.
- Gingival biotype \>1.5mm
- Systemically healthy subjects.
- Patients who are compliant.
- Patients who had not received any periodontal treatment in the last six months.
You may not qualify if:
- Pregnant and Lactating females.
- Aggressive periodontitis.
- Presence of pulpal or periapical involvement.
- Patients with known systemic diseases and conditions precluding any elective surgery.
- Patients who were smokers.
- Teeth with poor prognosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157, India
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Rashmi P, MDS
Krishnadevaraya College of Dental Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and HOD
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 11, 2019
Study Start
December 12, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
August 12, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share