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Effect of Blood-Derived i-PRF with Bone Graft Material on periapical Healing in Diabetic Patients

Impact of Homologous and Autologous i-PRF Polymerized with Hydroxyapatite on Periapical Healing in Uncontrolled Diabetic Patients A randomized controlled trial - nil

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084495
Enrollment
48
Registered
2025-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K044- Acute apical periodontitis of pulpal origin Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: intervention-I-PRF with hydroxyapatite : Autologous i-PRF is derived from the patient s own blood & mixed with hydroxyapatite (HA)which enhance bone regeneration Control Intervention1

Sponsors

Dr Surbhi Patel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All the patients for this study will be uncontrolled diabetic patients in which HbA1c is above and equal to 8 which will be used for the preparation of autologous injectable platelet rich fibrin 2)healthy Volunteers having HbA1c between 4.0-5.6 which will be used for the preparation of homologous injectable platelet rich fibrin

Exclusion criteria

Exclusion criteria: 1) Smokers or patients on anti-coagulant or anti-inflammatory therapy in past 4 weeks 2) Patients with blood dyscrasias, on immunosuppressant drugs, and alcoholics. 3) Pregnant and lactating mothers. 4) Patients having any acute infection, heart failure, and malignancy at the time of blood sampling insufficient blood/platelet count (platelet count less than 100,000 per mm).

Design outcomes

Primary

MeasureTime frame
Enhanced periapical healing as evidenced by radiographic reduction in periapical lesion size over a specified follow-up period.Timepoint: At baseline and 6 and 9 month intervals

Secondary

MeasureTime frame
Comparative efficacy of homologous versus autologous i-PRF in promoting healing. Timepoint: Broader Implications: The study may validate the use of advanced biomaterials in addressing the healing challenges associated with diabetes, potentially leading to more predictable endodontic outcomes

Countries

India

Contacts

Public ContactDr .Surbhi Patel

SPDC Wardha

surbhi17den@gmail.com9373050500

Outcome results

None listed

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