| CTRI Number |
CTRI/2025/01/079499 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Diagnostic
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficiency of non-invasive light source treatment with heated albumin mixed with platelet concentrate called as concentrated growth factors in the treatment of oral bone deficiency |
|
Scientific Title of Study
|
Effect of low level laser therapy and Activated plasma albumin gel in the treatment of intrabony defects using simplified papilla preservation flap a randomized control 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 |
DrShanmugaapriyan KR |
| Designation |
Post graduate |
| Affiliation |
SRM dental college ,Ramapuram |
| Address |
Department of periodontics,
PG block,
3rd floor PG clinic,
SRM Dental College,
Bharathi salai,
Ramapuram,
Chennai -600089
Chennai
TAMIL NADU
600089
India |
| Phone |
8489535751 |
| Fax |
|
| Email |
shanmu1203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Venkadassalapathy |
| Designation |
Professor |
| Affiliation |
SRM Dental College,Chennai |
| Address |
Department of periodontics,
PG block,
3rd floor PG clinic,
SRM Dental College,
Bharathi salai,
Ramapuram,
Chennai -600089
Chennai
TAMIL NADU
600089
India |
| Phone |
8148877084 |
| Fax |
|
| Email |
drsandev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh Venkadassalapathy |
| Designation |
Professor |
| Affiliation |
SRM Dental College,Chennai |
| Address |
Department of periodontics,
PG block,
3rd floor PG clinic,
SRM Dental College,
Bharathi salai,
Ramapuram,
Chennai -600089
Chennai
TAMIL NADU
600089
India |
| Phone |
8148877084 |
| Fax |
|
| Email |
drsandev@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Dental College,Ramapuram,Chennai-600089 |
|
|
Primary Sponsor
|
| Name |
DRShanmugaapriyan KR |
| Address |
Department of periodontics,
PG block,
3rd floor PG clinic,
SRM dental college,
Bharathi salai,
Ramapuram,
Chennai -600089
Tamilnadu
|
| 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 Shanmugaapriyan KR |
SRM dental college |
Department of periodontics
3rd floor PG clinic PG block
SRM dental college
Bharathi salai,Ramapuram Campus,Chennai600089
Chennai
TAMIL NADU |
8489535751
shanmu1203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Dental College,Instituitional Review Board |
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 |
| Intervention |
Activated plasma albumin gel in intrabony defects |
In intrabony defects placing a activated plasma albumin gel for regeneration of bone |
| Comparator Agent |
Concentrated growth factors in intrabony defects |
In intrabony defects placing a concentrated growth factor for regeneration of bone and follow up after 6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Intrabony defects with 2 or 3 walls
2)Defect angle less than 40°
|
|
| ExclusionCriteria |
| Details |
1) Patients requiring antibiotic prophylaxis before the periodontal examination
2) Sites with malocclusion and inadequate proximal contacts
3) Patients under immunosuppressive drugs
4) Patients with systemic disease that contraindicates periodontal surgery
5) Patients who are current smokers and pan chewers
6) Sites with non-accessible furcation involvement
7) Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ensure radiographic bone fill after 6months |
To ensure radiographic bone fill after 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess improvement in CAL,BOP and PPD |
Baseline and 6months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The aim of the study is to assess the efficacy of activated plasma albumin gel (APAG)which is prepared by mixing concentrated growth factors and denatured albumin to increase the halflife of growth factors .The APAG is then placed in intrabony defects of periodontitis patients to assess radiographic bone fill 6months later |