| CTRI Number |
CTRI/2024/09/074332 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical and Radiographic evaluation of a synthetic bone graft gel in the surgical treatment of patients with gum disease |
|
Scientific Title of Study
|
Clinical and radiographic evaluation of Poly Glycolic Acid / Poly Lactic Acid and hydroxyapatite paste in the treatment of periodontal intrabony 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 |
Dr Nileena Dilip |
| Designation |
post graduate student |
| Affiliation |
Rajiv Gandhi university of health sciences |
| Address |
room no.6, department of periodontics, vydehi institute of dental sciences and research centre, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
8884433882 |
| Fax |
|
| Email |
drnileenadilip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parichaya Batra |
| Designation |
senior lecturer |
| Affiliation |
Rajiv Gandhi university of health sciences |
| Address |
room no.6, department of periodontics ,vydehi institute of dental sciences and research centre, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
KARNATAKA
560066
India |
| Phone |
9035708131 |
| Fax |
|
| Email |
batraparichaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nileena Dilip |
| Designation |
post graduate student |
| Affiliation |
vydehi institute of dental sciences and research centre |
| Address |
room no.6, department of periodontics, vydehi institute of dental sciences and research centre, Nallurhalli, Whitefield, Bengaluru
KARNATAKA
560066
India |
| Phone |
8884433882 |
| Fax |
|
| Email |
drnileenadilip@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ghimas pharmaceutical house, Cimarosa, 85 - 40033 Casalecchio di Reno (BO) italy |
|
|
Primary Sponsor
|
| Name |
vydehi institute of dental sciences and research centre |
| Address |
vydehi institute of dental sciences and research centre, No 82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, |
| 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 Nileena Dilip |
vydehi institute of dental sciences and research centre |
department of periodontics, room no.6, whitefield
Bangalore
KARNATAKA |
8884433882
drnileenadilip@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: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison of Poly Glycolic Acid/Poly Lactic Acid with hydroxyapatite paste (fisiograft HA paste) and synthetic bone graft in the surgical treatment of periodontal intra bony defects at 3 months 6 months and 9 months of intervention |
comparison of Poly Glycolic Acid/Poly Lactic Acid with hydroxyapatite paste (fisiograft HA paste) and hydroxyapatite bone graft in the surgical treatment of periodontal intra bony defects as a split mouth study in patients with periodontitis at 3 months, 6 months and 9 months of intervention |
| Intervention |
surgical intervention |
surgical intervention of intra bony defects to evaluate the clinical and radiographic effect of Poly Glycolic Acid/Poly Lactic Acid with hydroxyapatite paste when compared with hydroxyapatite bone graft as active control in patients with periodontitis at 3 months, 6 months and 9 months of intervention |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 35 to 60 years.
Patients with stage III and stage IV periodontitis according to 2017 world workshop on periodontal and peri implant diseases and conditions.12
Presence of minimum of 16 natural teeth.
Presence of bilateral intrabony defects on Maxillary and mandibular premolar and molar teeth with the presence of two wall or three wall intra bony defect detected on radiograph. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Patients on any medications known to affect the outcomes of periodontal therapy.
Pregnant or lactating women
Smokers or subjects using any form of tobacco
1 wall- intrabony defect
Grade II and grade III mobile tooth. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in probing depth
Change in Relative attachment level
Percentage of bone fill
|
Change in probing depth
Change in Relative attachment level at baseline, 3 months 6 months and 9 months
Percentage of bone fill
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index by Silness and Loe 1964
Gingival index by Loe and Silness 1963
Clinical attachment level
|
9 months |
Plaque index by Silness and Loe 1964
Gingival index by Loe and Silness 1963
Clinical attachment level
|
9 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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="1"
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
|
This study is a randomized controlled split mouth clinical trial comparing the clinical and radiographic evaluation of Poly Glycolic Acid/Poly Lactic Acid and hydroxyapatite paste (fisiograft HA paste) with hydroxyapatite bone graft in the treatment of periodontal intrabony defects that will be conducted in Vydehi institute of dental sciences,Bangalore ,India. The primary outcome measures will be change in probing depth,Change in Relative attachment level and percentage of bone fill at the end of 9 months of surgery The secondary outcomes will be Plaque index, Gingival index and clinical attachment level at the end of 9 months of the study. |