| CTRI Number |
CTRI/2025/07/091013 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Treatment Using Tooth Powder Made from the Patients Own Tooth with Standard Gum Cleaning Surgery for Treating Deep Gum Problems |
|
Scientific Title of Study
|
Comparison Of Autologous Tooth Dentin Graft Versus Open Flap Debridement Alone In The Management Of Periodontal Intra bony Defects Randomized Controlled 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 |
Bala Karthiga V |
| Designation |
Post graduate student |
| Affiliation |
maulana azad institute of dental sciences |
| Address |
Room No 602
Floor No 6
Department of Periodontics
Maulana Azad Institute Of Dental Sciences
Mirdard Marg, Bahadur Shah Zafar Marg, LNJP Colony, New Delhi, Delhi,
New Delhi
DELHI
110002
India |
| Phone |
7339141830 |
| Fax |
|
| Email |
balakarthiga.16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shruti Tandon |
| Designation |
professor (SAG) |
| Affiliation |
maulana azad institute of dental sciences |
| Address |
Room No 602
Floor No 6
Department of Periodontics
Maulana Azad Institute Of Dental Sciences
New Delhi
DELHI
110002
India |
| Phone |
9654700982 |
| Fax |
|
| Email |
tandonshruti16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bala Karthiga V |
| Designation |
Post graduate student |
| Affiliation |
maulana azad institute of dental sciences |
| Address |
Room No 602
Floor No 6
Department of Periodontics
Maulana Azad Institute Of Dental Sciences
New Delhi
DELHI
110002
India |
| Phone |
7339141830 |
| Fax |
|
| Email |
balakarthiga.16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bala Karthiga V
Room No 602
Floor No 6
Department of Periodontics
Maulana Azad Institute Of Dental Sciences new delhi 110002 india |
|
|
Primary Sponsor
|
| Name |
Bala Karthiga V |
| Address |
Room No 602
Floor No 6
Department of Periodontics
Maulana Azad Institute Of Dental Sciences Mirdard Marg LNJP Colony New Delhi 110002 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bala Karthiga V |
b 35 jain mandir wali gali shakarpur laxmi nagar new delhi 110092 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bala karthiga V |
Maulana Azad Institute of dental sciences |
Room No 602
Floor No 6
Department of Periodontics
Central
DELHI |
7339141830
balakarthiga.16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Institute Of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontal Intra Bony defects in one or more teeth . |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autologous Tooth Dentin Graft along with open flap debridement will be compared with open flap debridement alone in the Management of Periodontal Intra-Bony Defect |
Autologous Tooth Dentin Graft along with open flap debridement will be compared with open flap debridement alone in the Management of Periodontal Intra-Bony Defect in the patients with minimum of one intra-bony defect and minimum of one indicated tooth for extraction |
| Intervention |
Autologous Tooth Dentin Graft will be obtained by grinding patients own tooth which indicated for extraction and placed in intra-bony defect after debridement |
Autologous Tooth Dentin Graft will be obtained by grinding patients own tooth which indicated for extraction and placed in intra-bony defect after debridement and probing depth , clinical attachment level and radiographic bone loss recorded at baseline and after 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either sex between the age group of 18-60 years, who sign informed consent for the study.
2.Systemically healthy subjects
3.Subjects with Periodontitis having probing pocket depth of greater than or equal to 6mm and clinical attachment level of greater than or equal to 6mm after phase I therapy in at least one tooth.
4.At least one site that radiographically shows vertical bone loss greater than or equal to 4 mm
5.Subjects having minimum of one maxillary or mandibular tooth indicated for extraction [non root canal treated tooth]
Non-smokers. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women or expected pregnancy during the study period.
2.Lactating women.
3.Presence of uncontrolled metabolic, endocrine, blood, neoplastic, or renal diseases.
4.History of Alcoholism or drug abuse.
5.Patients on any medication which is known to interfere with bone remodelling.
6.Any other conditions that might interfere with the analysis of the results. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in probing depth (PD) in the defect site .
Changes in clinical attachment level CAL in the defect site |
At Baseline , at One month , at Six month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radiographic Changes in the bone defect area BDA ( in mm2)
Any adverse reaction of Autologous Tooth Dentin grafts |
will be measured at baseline & after 6 months |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title Comparison of Autologous Tooth Dentin Graft Versus Open Flap Debridement Alone in the Management of Periodontal Intra Bony Defects A Randomized Controlled Trial
Background Periodontal intra bony defects are a significant clinical challenge due to the loss of tooth supporting structures. Autologous tooth dentin grafts have shown promising regenerative potential because they are rich in hydroxyapatite and growth factors. This study aims to compare the clinical and radiographic effectiveness of autologous dentin grafts with open flap debridement alone to evaluate their additional regenerative benefits.
Study Design Type of study is interventional Design is randomized parallel group active controlled clinical trial Blinding includes participant and outcome assessor blinded Sample size is 15 subjects Duration of study follow up to be inserted as per protocol
Participants Inclusion criteria Age between 18 to 60 years Male and female participants Diagnosed with chronic periodontitis with probing pocket depth of 6 millimeters or more Systemically healthy individuals
Exclusion criteria Smokers or tobacco users Pregnant or lactating women Patients with systemic illnesses such as uncontrolled diabetes or metabolic diseases History of periodontal surgery within the past 6 months
Interventions Group A test group receives autologous tooth dentin graft placed in the intrabony defect following open flap debridement Group B control group receives open flap debridement alone
Primary Outcome Measures Clinical parameters including reduction in probing pocket depth and gain in clinical attachment level
Secondary Outcome Measures Radiographic bone fill assessed through intraoral radiographs Observation of any adverse effects associated with the dentin graft
Randomization Method Randomization method is permuted block randomization fixed Allocation concealment is through sequentially numbered sealed opaque envelopes Blinding includes participant and outcome assessor |