"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"

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 - FUCO-PERIO trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085615

Enrollment

Registered

2025-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fucoidan hydrogel + Xenograft in one mandibular Grade II furcation site: One-time application at baseline with a follow-up period of 6 months Control Intervention1: Xenograft alone in t

Eligibility

Inclusion criteria

Inclusion criteria: Presence of bilateral mandibular Grade II furcation defects Systemically healthy Signed informed consent

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Clinical attachment level gain Probing depth reduction Radiographic bone fill Timepoint: 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

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Countries

India

Contacts

Public ContactMaria Sharon velraj

Saveetha institute of medical and technical sciences

arvinar.sdc@saveetha.com8124448902

Outcome results