| CTRI Number |
CTRI/2025/09/094843 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bone formation around natural teeth using placental extract gel and collagen sponge |
|
Scientific Title of Study
|
Comparative evaluation of collagen sponge with and without human placental extract gel in the treatment of furcation defects: A randomised 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 Pallam Sravani |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5, 2nd floor,
Department of Periodontology
Narayana Dental College and Hospital , Chintareddy palem,
SPSR Nellore district
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8919170358 |
| Fax |
|
| Email |
sravanipallam14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunupati Sumanth |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5, 2nd floor,
Department of Periodontology
Narayana Dental College and Hospital , Chintareddy palem,
SPSR Nellore district
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8885393855 |
| Fax |
|
| Email |
sumant29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunupati Sumanth |
| Designation |
Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no.5, 2nd floor,
Department of Periodontology
Narayana Dental College and Hospital , Chintareddy palem,
SPSR Nellore district
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8885393855 |
| Fax |
|
| Email |
sumant29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pallam Sravani |
| Address |
Room no 5, 2nd floor,
Department of Periodontology
Narayana Dental College and Hospital , Chintareddy palem,
SPSR Nellore district, 524003
Andhra pradesh, India |
| 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 Pallam Sravani |
Narayana Dental college and Hospital |
Room no.5, 2nd floor,
Department of Periodontology
Narayana Dental College and Hospital , Chintareddy palem,
SPSR Nellore district
Nellore
ANDHRA PRADESH |
8919170358
sravanipallam14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC,NDCH) |
Approved |
|
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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 |
0.1gm human placental gel admixed
collagen gel |
Open flap debridement will be done in target site and human placental gel admixed collagen sponge is placed into bony defect in the furcation area, the time of intervention will be 40 minutes |
| Comparator Agent |
collagen sponge |
Open flap debridement will be done in target site and collagen sponge is placed into bony defect in the furcation area. Time of intervention 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.systemically healthy individuals
2. Both males and females with age between 18 and 50 years having periodontitis with furcation defects
3.pocket depth greater than or equal to 5mm after non surgical periodontal therapy
4.Radiographic evidence of bone loss in the furcation area
5. participants who are co operative and able to come for regular follow up |
|
| ExclusionCriteria |
| Details |
1. pregnant and lactating women
2.who received antibiotic therapy in the previous 6 months
3.who underwent periodontal therapy in the past 6 months
4.use of tobacco in any form
5. medically compromised or under therapeutic regimen that may alter the probability of periodontal healing |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Amount of bone fill
Percentage of bone fill |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depth
clinical attachment level
Horizontal probing depth |
baseline,6 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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="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
|
Scaling and root planning will be done, oral hygiene instructions will be reinforced. Participants will be recalled after 4 weeks for re-evaluation of pocket depth. Participants with furcation defects will be chosen. Written informed consent will be taken.
Participants will be selected and randomly assigned into test and control sites by computer generated randomization method, Periodontal probing depth (PPD), clinical attachment level (CAL) will be measured using UNC-15 probe. Horizontal probing depth (HPD), will be measured using Naber’s probe by a single examiner. To standardize the Nabers probe angulation and position custom made acrylic stent will be used.
Group 1-Test site Open flap debridement and Collagen sponge and human placental extract gel. Group 2Control site Open flap debridement and Collagen sponge
In both test and control sites Kirkland flap will be raised and thorough debridement will be done followed by placement of human placental extract gel (Placentrex® Gel, ALBERT DAVID) Aqueous extract of 0.1gm of fresh human placenta with glutamic acid, leucine and lysine) plus collagen sponge (coloplug, cologenesis health care Pvt Ltd) into the bony defect of test site and collagen sponge (coloplug, cologenesis health care) alone in the control site. Then flap will be approximated with sutures.
Post-operative instructions will be given to the participants and will be recalled after 1 week for suture removal .In case of any discomfort participants are advised to report back. Clinical parameters will be taken at baseline and 6 months. |