| CTRI Number |
CTRI/2024/06/069193 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of horizontal bone loss in chronic periodontitis patients using bone graft and PRF |
|
Scientific Title of Study
|
Evaluation of effectiveness of Non-Incised Papilla Surgical Approach in the treatment of horizontal bone defects using allogenic bone graft and injectable platelet rich fibrin with or without platelet rich fibrin membrane in patients with periodontitis: A randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasad Dhadse |
| Designation |
Professor and HOD |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Peridontology, Sharad Pawar Dental college
Datta Meghe Institute of Higher Education and Research
Deemed to be University, Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
07415832733 |
| Fax |
|
| Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Bhatnagar |
| Designation |
PhD Scholar |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Peridontology, Sharad Pawar Dental college
Datta Meghe Institute of Higher Education and Research
Deemed to be University, Sawangi (Meghe) Wardha
Wardha
MAHARASHTRA
442107
India |
| Phone |
9822689401 |
| Fax |
|
| Email |
bhatnagarshruti9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Bhatnagar |
| Designation |
PhD Scholar |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Datta Meghe Institute of Higher Education and Research
Deemed to be University
Sawangi (Meghe) Wardha
MAHARASHTRA
442107
India |
| Phone |
07415832733 |
| Fax |
|
| Email |
bhatnagarshruti9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad pawar dental collegeand hospital, Datta meghe institute of higher education and research, meghe, sawangi, wardha, India, 442107 |
|
|
Primary Sponsor
|
| Name |
Shruti Bhatnagar |
| Address |
Department of Peridontology, Sharad Pawar dental college, Datta Meghe Institute of Higher Education and Research
Deemed to be University
Sawangi (Meghe) Wardha
|
| 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 Shruti Bhatnagar |
Department of Periodontology, Sharad Pawar dental college and hospital |
Department of Periodontology, Sharad Pawar dental college and hospital, Datta Meghe Institute of Higher Education and Research
Deemed to be University
Sawangi (Meghe) Wardha, Maharashtra, India 442107
Wardha
MAHARASHTRA |
07415832733
bhatnagarshruti9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, DHIMER |
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 |
DFDBA and i-PRF |
DFDBA and i-PRF will used in NIPSA teechnique, patient will be followed up till 9 months. |
| Intervention |
DFDBA and PRF membrane |
DFDBA and i-PRF along with PRF memebrane will used in NIPSA teechnique, patient will be followed up till 9 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
grade b chronic periodontitis patients |
|
| ExclusionCriteria |
| Details |
pregnant or lactating and systematically unhealthy patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Supralaveolar attachment gain, location of tip of papilla, width of keratinized tissue, pocket probing depth, relative attchment level, relative gingival recession, plaque index, gingival index |
Supralaveolar attachment gain (baseline and 9 months), location of tip of papilla (baseline and 9 months), width of keratinized tissue (baseline and 9 months), pocket probing depth (baseline 3 months, 6 months and 9 months), relative attchment level (baseline 3 months, 6 months and 9 months), relative gingival recession (baseline 3 months, 6 months and 9 months), plaque index (baseline 3 months, 6 months and 9 months), gingival index (baseline 3 months, 6 months and 9 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pocket probing depth, relative attchment level, relative gingival recession, plaque index, gingival index |
baseline, 6 months and 9 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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
|
this is a randomized controlled trial in which patients with grade B chronic periodontitis with supraalveolar defects will undergo a surgical intervention employing NIPSA technique. one group will receive DFDBA and i-PRF while other will receive DFDBA and i-PRF alond with PRF membrane. Primary outcome variables will be attachment gain, location of tip of papilla and width of keratinized tissue. secondary outcome variable will be pocket probing denth, plaque and gingival index |