| CTRI Number |
CTRI/2025/04/085615 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
"A Study to Compare the Healing of Bone Loss in Back Teeth Using a Natural Gel with Bone Graft Versus Bone Graft Alone in Adults with Gum Disease" |
|
Scientific Title of Study
|
A Randomized Controlled Split Mouth Clinical Trial Comparing the Effect of Fucoidan Hydrogel with Xenograft to Xenograft Alone on Periodontal Regeneration in Mandibular Grade II Furcation Defects |
| Trial Acronym |
FUCO-PERIO trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Sharon velraj |
| Designation |
Post graduate |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of periodontics
Saveetha dental college and hospitals
Saveetha institute of medical and technical sciences
Chennai
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
sharonvelraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvina R |
| Designation |
Associate professor |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of periodontics
Saveetha dental college and hospitals
Saveetha institute of Medical and Technical Sciences
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Maria Sharon velraj |
| Designation |
Post graduate |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of periodontics
Saveetha dental college and hospitals
Saveetha institute of Medical and Technical Sciences
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
sharonvelraj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maria sharon V |
| Address |
Department of periodontics
Saveetha dental college and hospitals
Saveetha institute of Medical and Technical Sciences
chennai 600077 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Maria Sharon velraj |
Saveetha dental college and hospitals |
Department of periodontics
Saveetha dental college and hospitals
Saveetha institute of Medical and Technical Sciences
Chennai
TAMIL NADU |
8124448902
sharonvelraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mandibular Grade II Furcation Defects in Chronic Periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fucoidan hydrogel + Xenograft in one mandibular Grade II furcation site |
One-time application at baseline with a follow-up period of 6 months |
| Comparator Agent |
Xenograft alone in the contralateral site of the same patient |
One-time application at baseline with a follow-up period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of bilateral mandibular Grade II furcation defects
Systemically healthy
Signed informed consent |
|
| ExclusionCriteria |
| Details |
Smokers
Systemic diseases (e.g., diabetes, immunocompromised)
Pregnant or lactating women
Allergy to study materials
Recent periodontal or antibiotic therapy (last 6 months) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical attachment level gain
Probing depth reduction
Radiographic bone fill
|
Clinical attachment level gain- measured at baseline and 6 months
Probing depth reduction- measured at baseline and 6 months
Radiographic bone fill- measured at baseline and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient-reported outcome measures (PROMs) – including postoperative pain, discomfort, & satisfaction assessed using a visual analog scale (VAS) at 1 week, 2 weeks, & 1 month post-surgery.
Gingival Index (GI) & Plaque Index (PI) – to monitor periodontal health status around treated sites at baseline, 3 months, & 6 months.
Soft tissue healing assessment – based on clinical healing index scores at 1 week & 2 weeks postoperatively. |
Patient-reported outcome measures (PROMs) – including postoperative pain, discomfort, & satisfaction assessed using a visual analog scale (VAS) at 1 week & 1 month post-surgery.
Gingival Index (GI) & Plaque Index (PI) – to monitor periodontal health status around treated sites at baseline & 6 months.
Soft tissue healing assessment – based on clinical healing index scores at 1 week, 3 months postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="6"
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
|
This randomized controlled split-mouth clinical trial aims to evaluate and compare the effectiveness of Fucoidan hydrogel combined with xenograft versus xenograft alone in the regeneration of mandibular Grade II furcation defects. Eligible patients presenting with bilateral Grade II furcation involvement in mandibular molars will be enrolled. In a split-mouth design, each patient will receive both treatment modalities: one site will be treated with Fucoidan hydrogel and xenograft (test group), while the contralateral site will receive xenograft alone (control group). Key clinical parameters, including probing depth, clinical attachment level, and radiographic bone fill, will be recorded and analyzed. The study will follow a double-blind design, where both participants and outcome assessors will be blinded to the allocation. The follow-up period for evaluation will be 6 months. |