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A Study Comparing Two Bone Graft Treatments for Gum Disease: Using Bone Graft Alone vs. Bone Graft with Natural Growth Factors from the Patients Own Blood - a Randomized Clinical Trial

Comparative Clinical and Radiographic Evaluation of Biphasic Calcium phosphate graft (B-OstIN HT) alone and Biphasic Calcium phosphate graft (B-OstIN HT) with autologous injectable platelet rich fibrin (i-PRF) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089116
Enrollment
40
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: Biphasic calcium phosphate alloplastic graft (B-OstIN HT) with autologous injectable platelet rich fibrin: 60 percent Hydroxyapatite and 40 percent Beta Tricalcium Phosphate(B-OstIN HT)

Sponsors

Dr Yatri Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in the age group between 25 to 60 yrs. 2. Patients diagnosed with Chronic Periodontitis. 3. Patients who are non-smokers or do not consume tobacco in any other form. 4. Patients who are in good systemic health with no contraindications to periodontal surgery. 5. Patients having pocket depths greater than 5mm, intraosseous defects greater than 3mm and with radiographic evidence of vertical / angular bone loss in the affected sites.

Exclusion criteria

Exclusion criteria: 1. One-walled osseous defects. 2. Patients suffering from any systemic diseases or with a compromised immune system. 3. Patients who had received any type of periodontal therapy for the past 6 months. 4. Patients taking immunosuppressant drugs like corticosteroids. 5. Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study. 6. Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.

Design outcomes

Primary

MeasureTime frame
1) Plaque Index (P.I) Tureskey-Gilmore-Glickman Modification of Quigley Hein) 2.Gingival Index (G.I) (Loe and Sillness,1963) 3.Probing Pocket Depth (PPD) 4.Clinical Attachment Level (CAL)Timepoint: 1) At Baseline 2) After 1 month 3) After 3 month 4) After 6 month

Secondary

MeasureTime frame
The radiographic bone fill will be evaluated using Intraoral Periapical Radiographs of the surgical site.Timepoint: At Baseline, immediately after the surgery and 6 months post surgery.

Countries

India

Contacts

Public ContactDr Mala Dixit Baburaj

NAIR HOSPITAL DENTAL COLLEGE

maladixit25@gmail.com9223340938

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026