"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"

Phase 2

Not yet recruiting

• Conditions: Mandibular Grade II Furcation Defects in Chronic Periodontitis

• Registration Number: CTRI/2025/04/085615
• Lead Sponsor: Maria sharon V

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**.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Presence of bilateral mandibular Grade II furcation defects Systemically healthy Signed informed consent.

Exclusion Criteria

Smokers Systemic diseases (e.g., diabetes, immunocompromised) Pregnant or lactating women Allergy to study materials Recent periodontal or antibiotic therapy (last 6 months).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probing depth reduction	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
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
Clinical attachment level gain	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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Saveetha dental college and hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Saveetha dental college and hospitals

🇮🇳Chennai, TAMIL NADU, India

Maria Sharon velraj

Principal investigator

8124448902

sharonvelraj@gmail.com