| CTRI Number |
CTRI/2025/08/092749 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COLLAGEN MEMBRANES WITH BONE POWDER MIXED WITH PATIENTS OWN BLOOD IN THE TREATMENT OF BONE DEFECTS |
|
Scientific Title of Study
|
Comparitive evaluation of Biomesh and Healiguide GTR membranes with sticky bone in the treatment of intraosseous defects– A split mouth study |
| 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 Sai Pragathi |
| Designation |
Post graduate student |
| Affiliation |
Vydehi college of dental sciences and research centre |
| Address |
Department of periodontics,room number 6,
Vydehi college of dental sciences, Bangalore
Vydehi college of dental sciences, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9606192641 |
| Fax |
|
| Email |
drsaipragathireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shruthi s |
| Designation |
Reader |
| Affiliation |
Vydehi college of dental sciences, Bangalore |
| Address |
Department of periodontics,room number 6,
Vydehi college of dental sciences, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
9886824276 |
| Fax |
|
| Email |
shruthi_s1984@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shruthi s |
| Designation |
Reader |
| Affiliation |
Vydehi college of dental sciences, Bangalore |
| Address |
Department of periodontics,room number 6,
Vydehi college of dental sciences, Bangalore
KARNATAKA
560066
India |
| Phone |
9886824276 |
| Fax |
|
| Email |
shruthi_s1984@yahoo.com |
|
|
Source of Monetary or Material Support
|
| 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066,India. |
|
|
Primary Sponsor
|
| Name |
Dr Sai pragathi |
| Address |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sai Pragathi |
Vydehi institute of dental sciences and research center |
Department of periodontics,room number 6, second floor
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA |
09606192641
drsaipragathireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi institute of dental sciences institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biomesh and sticky bone |
In recent years, biological barrier membranes have gained importance in periodontal Regeneration one such membrane BioMesh® (Samyang Corporation, Korea) is a Combination of polylactide and polyglycolide.Duration is 9 months |
| Comparator Agent |
BIOMESH AND HEALIGUIDE GTR MEMBRANES WITH STICKY BONE |
Healiguide®, a xenogenic origin COLLAGEN MEMBRANE |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 35to 50 years.
Presence of minimum of 16natural teeth.
Maxillary and mandibular molars with the presence of two wall or three wall intra bony defect greater than 3mm as detected on radiography
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Patients on any medications known to affect the outcomes of periodontal therapy
Insufficient platelet count
Pregnant or lactating women
Smokers or subjects using any form of tobacco
Furcation involvement more than 3mm
Grade 2 and grade 3 mobility
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in probing pocket depth.
Clinical attachment level gain.
Radiographic bone defect fill.
|
BASELINE AND 9 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased bleeding on probing.
Reduction in plaque index score.
|
BASELINE AND 9 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All routine tests will be carried out before starting the surgery. The surgical procedure will be performed under local anesthesia using 2% lignocaine hydrochloride containing adrenaline at a concentration of 1: 200000.A full thickness mucoperiosteal flap will be raised and the intra bony defect will be debrided and Injectable Platelet Rich Fibrin (I- PRF) will be obtained from the patient. The defect will be filled with sticky bone and Biomesh in Group A and sticky bone and Healiguide in Group B and suturing will be done.
|