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

NCT ID: NCT04195295

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2021-11-30

Brief Summary

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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

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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.

Conditions

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Intrabony Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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periosteal membrane and egg shell graft

Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane.

Group Type EXPERIMENTAL

Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane

Intervention Type PROCEDURE

* 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

only egg shell graft

Only Egg shell derived nano hydroxyapatite (EnHA) as graft material.

Group Type EXPERIMENTAL

Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material

Intervention Type PROCEDURE

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.

open flap debridement

open flap debridement procedure only.

Group Type ACTIVE_COMPARATOR

Open flap debridement procedure in intrabony defects.

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Prabhuji MLV

Professor and HOD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Rashmi P, MDS

Role: PRINCIPAL_INVESTIGATOR

Krishnadevaraya College of Dental Sciences

Locations

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Krishnadevaraya college of dental sciences

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr. Rashmi P, MDS

Role: CONTACT

9900925844

Dr. Sri Vani T. M, MDS

Role: CONTACT

9406443033

Facility Contacts

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Rashmi P, MDS

Role: primary

9900925844

Other Identifiers

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02_D012_102133

Identifier Type: -

Identifier Source: org_study_id

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