| CTRI Number |
CTRI/2024/08/072510 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using bone grafts to treat individuals with gum diseases who have bone defects |
|
Scientific Title of Study
|
Comparative evaluation of the clinical and radiographic outcomes of Nanohydroxyapatite bone graft with and without Chitosan Nanohydrogel in periodontal bony defects A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BODIMALLA SANDHYA |
| Designation |
Postgraduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room No 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
INDIA
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9014615153 |
| Fax |
|
| Email |
sr1420979@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SREENIVAS NAGARAKANTI |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room No 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
INDIA
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SREENIVAS NAGARAKANTI |
| Designation |
Professor and Head |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room No 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003
INDIA
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR BODIMALLA SANDHYA
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
Nellore
ANDHRA PRADESH
524003 |
|
|
Primary Sponsor
|
| Name |
BODIMALLA SANDHYA |
| Address |
Postgraduate
Room no 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
524003 |
| Type of Sponsor |
Other [Self (Principal Investigator)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR BODIMALLA SANDHYA |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
Room No 5
Second Floor
Department of Periodontology
Narayana Dental College and Hospital
Chintareddy Palem
Nellore
524003
Andhra Pradesh
INDIA
Nellore
ANDHRA PRADESH |
9014615153
sr1420979@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NARAYANA DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Periodontal bony defects will be treated by using nanohydroxyapatite bone grafts |
The entire procedure will be performed under local anesthesia and aseptic conditions. Kirkland flap will be raised, and thorough debridement will be done followed by placement of nanohydroxyapatite bone graft and then flap will be approximated and sutures. post operative instructions will be given to the participants and will be recalled after 1 week for suture removal. |
| Intervention |
Periodontal bony defects will be treated by using nanohydroxyapatite bone graft with chitosan nanohydrogel |
The entire procedure will be performed under local anesthesia and aseptic conditions. Kirkland flap will be raised, and thorough debridement will be done followed by placement of nanohydroxyapatite bone graft with chitosan nanohydrogel and then flap will be approximated and sutures. post operative instructions will be given to the participants and will be recalled after 1 week for suture removal. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are systemically healthy.
Both males and females with age ≥ 30 years having periodontitis with bilateral similar bony defects.
Pocket depths ≥5mm after phase I evaluation
Bilateral bony defect of depth ≥ 2mm measured with CBCT.
Radiographic evidence of bone loss.
Absence of periapical pathology.
Participants who are co-operative and able to come for regular follow-up.
|
|
| ExclusionCriteria |
| Details |
who will be known to have a systemic condition, those taking antiresorptive medicines or immunosuppressants or corticosteroids.
Patients with poor oral hygiene,
Patients those with a history of unfavourable oral habits.
Patients who underwent periodontal therapy in the past six months,
Pregnant or nursing mothers.
Individuals who are known allergic to chitosan products or graft components
Medically compromised or under therapeutic regimen that may alter the probability of periodontal healing.
Use of tobacco in any form.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in amount of bone fill and percentage of bone fill |
Baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare change in Probing depth (PD), Clinical attachment level (CAL) and Gingival bleeding index.
|
Baseline , 1month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim: The aim of this present study is to evaluate the efficacy of Chitosan Nanohydrogel along with Nano Hydroxyapatite bone graft compared to Nano Hydroxyapatite bone graft alone, in the treatment of Periodontal Bony Defects.All the participants will be explained about the aim, nature, and design of the study along with a written informed consent for their participation before the commencement of the study. The study is planned as a randomized clinical trial conducted in individuals with bilateral periodontal bony defects. The study duration is 9-12 months in which the radiographic parameters will be recorded at baseline and 6 months and clinical parameters will be recorded at baseline, 1 and 6 months. The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013. The radiographic parameters include: 1) Amount of bone fill. 2) Percentage of bone fill. The clinical parameters for assessment include: 1) Periodontal probing depths (PD) 2) Clinical attachment levels (CAL) 3) Gingival Bleeding Index (GBI) All patients included in the study will be evaluated before the treatment procedure and patients with bilateral periodontal bony defects are selected. Two sites left and right halves of the maxillary and mandibular arches will be selected and assigned as test and control group. Test group: Open flap debridement with Chitosan Nanohydrogel with Nanohydroxyapatite bone graft placement. Control group: Open flap debridement with Nanohydroxyapatite bone graft placement. Procedure: Participants with periodontal disease will be selected from the outpatient Department of Periodontology depending on the inclusion criteria and then thorough scaling and root planning will be done. Participants will be recalled after 4 weeks for re-evaluation of pocket depth. Participants with bilateral bony defects will be chosen. 30 sites from 15 patients will be selected and randomly assigned into test and control sites by computer generated randomization method. The customized acrylic occlusal stent will be prepared, which serves as a guide for standardization during the evaluation of clinical parameters (Periodontal probing depths, clinical attachment levels) . In both test and control sites, under local anesthesia, Kirkland flap will be raised, and thorough debridement will be done followed by placement of CNHG + NHA BG in the bony defect of test site and NHA BG alone in the control site. Then flap will be approximated, and sutures. The bone graft used for this study is commercially available and chitosan Nanohydrogel is prepared in PERIOBIOLOGICS LLP laboratory. Post operative instructions will be given to the participants and will be recalled after 1 week for suture removal. In case of any discomfort participants are advised to report back
|