Efficacy of 1% Metformin Gel Mixed With PRF in Augmenting Narrow Ridge
MF
1 other identifier
interventional
2
1 country
1
Brief Summary
This study aimed to evaluate the efficacy of 1% metformin gel mixed with PRF, in horizontal ridge augmentation with the split-crest technique, for implant placement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedJune 14, 2022
June 1, 2022
1 year
March 28, 2022
June 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical parameter to measure difference
Implant stability (resonance frequency analysis)
to detect change from baseline at time (immediately after implant insertion) and after 6 months.
Secondary Outcomes (1)
Radiological assessment to measure difference
to detect change from baseline (immediately after surgery), at time of loading (6 months), and 6 months after loading
Study Arms (2)
metformin
EXPERIMENTALwill receive split-crest technique by ultrasonic bone surgery with implant placement and PRF mixed with 1% metformin gel
control
NO INTERVENTIONwill receive split-crest technique by ultrasonic bone surgery with implant placement without gap filling.
Interventions
metformin (MF), an antidiabetic agent, has been successfully used as a local drug delivery agent in periodontitis patients. Literature has suggested that MF possesses the osteogenic potential and induces the growth of osteoblast precursor cells. Therefore, several human studies have reported the use of MF alone or combined with PRF in the treatment of bony defects
Eligibility Criteria
You may qualify if:
- Adults (age 18-50) exhibiting initial insufficiently bone ridge.
- Patients with good oral hygiene.
- Free from systemic diseases that may influence the outcome of the therapy.
You may not qualify if:
- Heavy smokers.
- Patient treated by immunosuppressive chemotherapy or radiotherapy,
- Allergy to any material or medication used in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AlAzhar universty
Cairo, 04444, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor at AlAzharU department of Periodontology
Study Record Dates
First Submitted
March 28, 2022
First Posted
June 14, 2022
Study Start
June 15, 2022
Primary Completion
June 15, 2023
Study Completion
June 15, 2023
Last Updated
June 14, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share