| CTRI Number |
CTRI/2024/12/078436 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
checking the level of bone growth with and without application of vitamin c mixed with bone graft around teeth with bone loss |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of periodontal bony defect fill with and without ascorbic acid admixed nanohydroxyapatite bone graft. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Sai Charitha |
| Designation |
Postgraduate |
| Affiliation |
Narayana Dental College And HOSPITAL,NELLORE |
| Address |
Department of Periodontology, Room no. -5,Narayana Dental College And Hospital, Chintareddypalem, Nellore, Andhrapradesh, India -524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8341244859 |
| Fax |
|
| Email |
rajindisha.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumanth Gunupati |
| Designation |
Professor |
| Affiliation |
Narayana Dental College And HOSPITAL,NELLORE |
| Address |
Dept of Periodontology, Room no. -5,Narayana Dental College And Hospital, Chintareddypalem, Nellore, Andhrapradesh, India -524003
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9848385378 |
| Fax |
|
| Email |
sumant29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumanth Gunupati |
| Designation |
Professor |
| Affiliation |
Narayana Dental College And HOSPITAL,NELLORE |
| Address |
DEPT OF PERIODONTOLOGY, ROOM NO. -5,Narayana Dental College And Hospital, Chintareddypalem, Andhrapradesh, India -524003
ANDHRA PRADESH
524003
India |
| Phone |
9848385378 |
| Fax |
|
| Email |
sumant29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N Sai Charitha, Department of Periodontology, Room no- 5,Narayana Dental College and
Hospital, Chintareddypalem, Nellore-524003, Andhra
Pradesh, INDIA. |
|
|
Primary Sponsor
|
| Name |
Dr N Sai Charitha |
| Address |
Department of Periodontology,Room no-5,Narayana Dental College and Hospital, Chintareddypalem, Nellore-524003, Andhra Pradesh., INDIA. |
| Type of Sponsor |
Other [self] |
|
|
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 N Sai Charitha |
Narayana Dental College And Hospital |
Department of Periodontology,Room no-5 Narayana Dental College and Hospital, Chintareddypalem, Nellore-524003, Andhra Pradesh, INDIA.
Nellore
ANDHRA PRADESH |
8342144859
rajindisha.ss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontal disease with bony defects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.2%mM ascorbic acid gel admixed nanohydroxyapatite bone graft |
open flap debridement will be done in target site and ascorbic acid admixed nanahydroxyapatite bonegraft is placed into intraoral bony defect, the time of intervention will be 40 minutes |
| Comparator Agent |
Nano Hydroxy Apatite Bonegraft |
open flap debridement will be done in target site and nanohydroxyapatite bone graft is placed into the bony defect. Time of intervention 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Both |
| Details |
Who are systemically healthy
Both males and females with age ≥30 years having periodontitis with bilateral bony defects.
Pocket depths ≥5 mm after phase 1 evaluation.
Radiographic evidence of bone loss.
Participants who are co‑operative and able to come for regular follow-up.
Participants with ≥20 remaining teeth
|
|
| ExclusionCriteria |
| Details |
Pregnant/lactating women
Individuals who are known allergic to
ascorbic acid.
Who received antibiotic therapy in the previous 6 months
Who underwent periodontal therapy in the past 6 months
Use of tobacco in any form
Medically compromised or under therapeutic regimen that may alter the probability of periodontal healing
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depths(PD)
Clinical attachment levels(CAL)
amount of bone fill
Amount of bone fill
|
baseline,one month,6 months & 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival Bleeding Index
Percentage Of Bonefill |
Baseline,one months,six months,9 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 4 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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)
|
N/A |
|
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 the present study is to evaluate clinical and Radiographic evaluation of periodontal bony defects with and without Ascorbic acid admixed nano hydroxyappatite bone grafts
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 healthy individuals with Periodontitis. the study duration is 9 months in which clinical parameters will be recorded at baseline, 1 month and 6 months. Radiographic parameters will be recorded at baseline, 1 month, 6 months and 9 months.
The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013.
The clinical parameters for assessment include
1. Periodontal Probing Depth
2. Clinical Attachment Levels.
3. Gingival Bleeding Index
The radiographic parameters for assessment include
1. amount of bone fill
2. percentage of bone fill
All the patients included in this study will be evaluated before the treatment procedure and patients with periodontal bony defects will be selected.
Two sites left and right halves of the maxillary or mandibular rch will be selected and assigned as test and control groups.
Test group: Ascorbic acid admixed nano hydroxyapatite bone graft
Control group: hydroxyapatitie graft
Procedure: a split mouth design will be followed, where the bilateral quadrants with bony defects will be chosen. 30 sites from 15 patients will be selected and grouped as test and control site.
Clinical parameters will be recorded at baseline, 1 month, and 6 months, radiographic parameters will be recorded at baseline, 1 month, 6 months and 9 months in both the test and control groups.
Open flap debridement will be performed to all patients and nano hydroxyapatite bone graft will be placed in control site and ascorbic acid admixed nano hydroxyapatite bone graft will be placed in test sites.
Post operative instructions will be given to all the patients and will be recalled after 1 week for suture removal.
In any case of discomfort, patients are advised to report back
All the patients will be recalled again after 1 month, 6 & 9 months for re-evaluation of clinical and radiographic parameters in both test and control groups.
|