| CTRI Number |
CTRI/2025/04/084507 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of different materials used for bone filling to improve gum health |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Amnioguard (Guided Tissue Regenration Membrane) in combination with NovaBone Putty and Advanced-Platelet Rich Fibrin (A-PRF Membrane) in combination with NovaBone Putty in the Regeneration of Human Periodontal Infrabony Defects – A Randomized Controlled 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 |
Geeta Jagdish Bhandari |
| Designation |
Post graduate Student |
| Affiliation |
Datta Meghe Institute if Higher Education And Reaserch |
| Address |
Department of Periodontics, Room no.3, Sharad Pawar Dental College, Sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
08237719188 |
| Fax |
|
| Email |
gjb12286@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Geeta Jagdish Bhandari |
| Designation |
Post graduate Student |
| Affiliation |
Datta Meghe Institute if Higher Education And Reaserch |
| Address |
Department of Periodontics, Room no.3, Sharad Pawar Dental College, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
08237719188 |
| Fax |
|
| Email |
gjb12286@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geeta Jagdish Bhandari |
| Designation |
Post graduate Student |
| Affiliation |
Datta Meghe Institute if Higher Education And Reaserch |
| Address |
Department of Periodontics, Room no.3, Sharad Pawar Dental College, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
08237719188 |
| Fax |
|
| Email |
gjb12286@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Reasearch, Sawangi, Meghe, Wardha, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe of Higher Education and Reasearch |
| Address |
Sawangi Meghe, Wardha, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Geeta Jagdish Bhandari |
Sharad Pawar Dental College |
Department of Periodontics, Room no. 3, Sharad Pawar Dental College, Sawangi Meghe
Wardha
MAHARASHTRA |
08237719188
gjb12286@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Dtta Meghe Insttitute of Higher Education and Reaserch |
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 |
Novabone putty and A-PRF |
Novabone putty covered with Autologous PRF membrane will be placed into the osseous defect with light pressure till it is filled up to the most coronal level of osseous wall by raising the flap. The flap will be coronally repositioned and sutured in such a way that the flap margin will be located 1 to 2 mm coronal to CEJ, ensuring primary flap closure. A combination of vertical mattress suture and interproximal sutures will be used to secure the flap in position. The assessment will be done at 3 and 6 months. |
| Intervention |
Novabone putty and Amnioguard |
Novabone putty covered with Amnioguard membrane will be placed into the osseous defect in control site with light pressure till it is filled up to the most coronal level of osseous wall by raising the flap. The flap will be coronally repositioned and sutured in such a way that the flap margin will be located 1 to 2 mm coronal to CEJ, ensuring primary flap closure. A combination of vertical mattress suture and interproximal sutures will be used to secure the flap in position. The assessment will be done at 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Presence of at least 1 or 2 radiographically detectable interproximal infrabony osseous defect with probing depth 5mm and clinical attachment loss 5mm following initial therapy.
2)Depth of intraosseous component of the defect
3)A radiographic base of the defect at least 3mm coronal to the apex of the tooth.
4)Presence of at least 3mm width of keratinized gingiva around test teeth to allow complete soft tissue coverage of the defect. |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone periodontal therapy in last 6
months.
2. Patients who had received antibiotic therapy during the previous
three months.
3. Individuals who are expecting or who have allergies to the drugs in
study.
4. Pregnant ladies and lactating mothers .
5. Regular users of mouthwash.
6. Chronic alcoholics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Radiographic Bone Fill in Infrabony defects at 6
months post-surgery.
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Gain in Clinical Attachment Level(CAL)
2)Reduction in Probing Pocket Depth
|
6 months
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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)
|
Not Applicable |
| 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
|
Periodontal regeneration is challenging because it requires the predictable regeneration of three very distinct and varied tissues (such as cementum, PDL, and bone) as well as a triphasic contact between them in order to guarantee the repair.The aim of this study is to compare
and evaluate the effectiveness of amnioguard in combination with novabone putty
and A-PRF membrane in combination with novabone putty in the regeneration of
human periodontal intrabony defects using Cone Beam Computed Tomography(CBCT). Twenty-four individuals in good systemic health will be treated with novabone putty and autologous PRF (Group-A) f in combination with amnioguard in combination with novabone putty (Group-B) for twenty-four periodontal infrabony defects. Clinical and radiographic features will be evaluated before surgery and six months following the procedure. The final data will be subjected to statistical analysis. |