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Comparision of two materials for increasing the width of alveolar ridge

Efficacy of interpositional 1% Metformin enriched platelet rich fibrin (PRF) compared to Decalcified freeze-dried bone allograft with PRF following staged peizotome assisted ridge splitting of narrow edentulous ridge for implant placement – a randomized controlled study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061511
Enrollment
30
Registered
2024-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: K063- Horizontal alveolar bone loss

Interventions

Intervention1: Alveolar ridge split with 1% Metformin and platelet rich fibrin in 1:1 ratio at the surical site.: A para-crestal incision followed by two vertical releasing incisions will be done usin

Sponsors

Government Dental College And Research institute Bangalore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Having good general health. Sufficient alveolar ridge height Narrow ridges min 3mm and less than 6mm with intercortical plate.

Exclusion criteria

Exclusion criteria: • Subjects with residual infection in the edentulous area • Subjects with poor oral hygiene Untreated/persisting periodontal disease • Previous history of horizontal bone augmentation • Using any drug that that affect bone metabolism • History of radiotherapy in head and neck region • Presence of dense cortical bone. (D1-Misch classification)7 • Presence of severe undercuts • Presence of parafunctional habits • Unfavourable ridge relationship • Missing antagonist teeth at the edentulous site • Vulnerable groups (e.g., HIV patients, pregnancy and lactating mothers etc)

Design outcomes

Primary

MeasureTime frame
Changes in alveolar bone width assessed clinically . Implant primary stability (seating torque) at the time of implant placement Timepoint: 2months 2months 2months

Secondary

MeasureTime frame
1. Implant survival rate (ANNEXURE5) 2. To assess pain discomfort (VAS scale). 3. To assess suppuration, bone fracture, swelling noted postoperatively, categorised as present/absent 4. Comparative analysis of newly formed bone and comparable proportion residual biomaterial as assessed histologically. 5. Marginal bone loss.Timepoint: Implant survival rate after 6 months of loading. 7. Marginal bone loss after 6 months of loading.

Countries

India

Contacts

Public ContactDr KHAN SABERA KALIMUDDIN

Government dental college and research institute

periosmitha@gmail.com09449630572

Outcome results

None listed

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