Intrabony Periodontal DefectNCT04195295
Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification
A study testing Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane, Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and Open flap debridement procedure in intrabony defects. in people with Intrabony Periodontal Defect, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Periodontal Defect
- What is being tested?
- Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane, Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and Open flap debridement procedure in intrabony defects.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 12 Dec 2019to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Krishnadevaraya college of dental sciences
Bangalore, Karnataka, 562157
Rashmi P, MDS, 9900925844, rashparams2005@yahoo.co.in
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrabony Periodontal Defect
- Being tested
- Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane, Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material, Open flap debridement procedure in intrabony defects.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier MembraneProcedure or surgery
- 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
Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft materialProcedure or surgery
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 procedure in intrabony defects.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| periosteal membrane and egg shell graft | Experimental | Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane. Receives: Procedure: Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane |
| only egg shell graft | Experimental | Only Egg shell derived nano hydroxyapatite (EnHA) as graft material. Receives: Procedure: Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material |
| open flap debridement | Active comparator | open flap debridement procedure only. Receives: Procedure: Open flap debridement procedure in intrabony defects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone defect fill and density
bone defect fill and bone density will be measured pre operatively and post operatively using CBCT
Measured: 6 months
Secondary outcomes (1)
Probing pocket depth
probing pocket depth is measured using UNC 15 probe pre operatively and post operatively
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start12 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- Dr. Rashmi P, MDS, Principal investigator, Krishnadevaraya College of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195295
- Sponsor's protocol ID
- 02_D012_102133
- Status last verified
- Aug 2020
- First submitted
- 6 Dec 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, Derived From Egg Shell Along With Periosteum as Barrier Membrane Under Magnification - An Interventional Study
- ClinicalTrials.gov ID
- NCT04195295
- Acronym / sponsor ID
- 02_D012_102133
- Conditions
- Intrabony Periodontal Defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periosteal membrane and egg shell graft | Experimental | Procedure: Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier MembraneEgg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and periosteal pedicle as barrier membrane. |
| only egg shell graft | Experimental | Procedure: Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft materialOnly Egg shell derived nano hydroxyapatite (EnHA) as graft material. |
| open flap debridement | Active comparator | Procedure: Open flap debridement procedure in intrabony defects.open flap debridement procedure only. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | periosteal membrane and egg shell graft |
| Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft materialFull 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. | Procedure or surgery | only egg shell graft |
| 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. | Procedure or surgery | open flap debridement |
Primary outcome
Bone defect fill and density
Time frame: 6 months
bone defect fill and bone density will be measured pre operatively and post operatively using CBCT
1 secondary outcome
Probing pocket depth
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Rashmi P, MDS principal investigator
Krishnadevaraya College of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane, Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material and Open flap debridement procedure in intrabony defects. in people with Intrabony Periodontal Defect, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rashmi P, MDS (9900925844, rashprams2005@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone defect fill and density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.