| CTRI Number |
CTRI/2025/09/094168 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two treatments for gum bone loss in molars: surgery and no surgery using Emdogain |
|
Scientific Title of Study
|
Outcome assessment of minimally invasive non-surgical therapy (MINST) in combination with emdogain versus guided tissue regeneration combination therapy for class II mandibular furcation defects. A randomized controlled 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 ATHUL KRISHNA P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE KOTTAYAM |
| Address |
PUZHAKKARA HOUSE
MUNDATHIKODE PO
THRISSUR
GOVERNMENT DENTAL COLLEGE KOTTAYAM
GANDHINAGAR PO
686008
Thrissur
KERALA
680601
India |
| Phone |
7994277322 |
| Fax |
|
| Email |
athulkrishnaathul773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BAIJU RM |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
government dental college kottayam |
| Address |
GOVERNMENT DENTAL COLLEGE
KOTTAYAM
Thrissur
KERALA
686008
India |
| Phone |
9447279605 |
| Fax |
|
| Email |
baijurm2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ATHUL KRISHNA P |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
government dental college kottayam |
| Address |
PUZHAKKARA HOUSE
MUNDATHIKODE PO
THRISSUR
government dental college kottayam
gandhinagar po
686008
Thrissur
KERALA
680601
India |
| Phone |
7994277322 |
| Fax |
|
| Email |
athulkrishnaathul773@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Athul krishna P |
| Address |
government dental college kottayam gandhinagar po 686008
Kottayam
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 Athul krishna P |
government dental college kottayam |
government dental college kottayam gandhinagar po 686008
Kottayam
KERALA
India
Kottayam
KERALA |
7994277322
athulkrishnaathul773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee (IEC/Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guided tissue regeneration (GTR) with a barrier membrane. |
GTR involves the placement of a barrier membrane to facilitate selective cell repopulation and regeneration of periodontal tissues, providing structural support for healing in Class II mandibular furcation defects.6 months clinical evaluations at baseline, 3 months, and 6 months |
| Intervention |
Minimally invasive non-surgical therapy (MINST) with Emdogain. |
MINST involves a conservative periodontal therapy performed with minimal tissue manipulation, combined with Emdogain, an enamel matrix derivative designed to promote periodontal tissue regeneration and healing.with clinical evaluations at baseline, 3 months, and 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Class II mandibular furcation defects. (Hamp et al 1975)
Systemically healthy
Sound Endodontic status
Adequate keratinized gingiva |
|
| ExclusionCriteria |
| Details |
Pregnancy or lactation.
Uncontrolled diabetes
Smokers
History of allergy to any components of emdogain.
Use of medications affecting periodontal health (e.g., bisphosphonates).
Inability to undergo surgical procedures.
Recent antibiotic medication history
Class III furcation defects (Hamp et al 1975)
Patients unwilling to participate due to social/religious reasons for use of emdogain |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the post treatment (one year) clinical attachment level (CAL) in patients treated
with Class II mandibular furcation defects with MINST combined with emdogain compared to
GTR combination therapy |
3rd month,6th month,one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the Post treatment (one year) reduction in probing pocket depth (PPD),
gingival recession, horizontal clinical attachment level (HCAL) between Emdogain
combined with MINST compared to GTR combination therapy in patients with Class II
mandibular furcation defects.
2. Procedure time, post operative pain (Visual analogue scale (VAS) Score and no. of
Analgesics used) among the two groups. |
3rd month,6th month,one year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/10/2025 |
| Date of Study Completion (India) |
21/04/2026 |
| Date of First Enrollment (Global) |
04/10/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|