Metformin Gel, Bone Graft, Immediate Dental Implants
Conditions
Brief summary
This study aimed to investigate whether combining xenografts with Metformin Gel gel enhances bone regeneration and improves implant outcomes.
Detailed description
The placement of a dental implant in an extraction socket at the time of extraction or explanation is known as immediate implant placement whereas delayed placement of implant signifies the implant placement in edentulous areas where healing has completed with new bone formation after the loss of tooth/teeth. The xenograft is derived from other organisms, mainly bovine. It provides long-term volume stability. Porous natural hydroxyapatite can be obtained from animal bones. Metformin HCl (1, 1-dimethylbiguanide HCl) (MF), is one of the most commonly used oral anti-hyperglycemic agents for the treatment of type 2 diabetes mellitus. The use of MF may reduce the association between diabetes and fractures in patients with both type 1 and type 2DM.MF increase type I collagen production in osteoblast-like cell lines and stimulated alkaline phosphate activity in osteoblasts.
Interventions
OTHERMetformin gel-xenograft
Patients received immediate implant combined with a mixture of 1%metformin gel and xenograft.
OTHERXenograft
Patients received immediate implant combined with xenograft alone.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 40 years. * Both sexes. * Adult individual with non-restorable tooth in esthetic and premolars area and seeking for immediate implant placement. * Systemically healthy patients were selected for implant surgery according to the criteria of Cornell medical index and its modifications. * The recipient site of the implant should be free from any pathological conditions. * Sufficient vertical bone height to safely place at least 12 mm long dental implant.
Exclusion criteria
* Smokers. * Pregnant or lactating female patients. * Patients with parafunctional habits such as bruxism and clenching. * Presence of acute infection around the failing tooth. * Perforation and/or loss of the labial bony plate following tooth removal and/or implant osteotomy. * Inability to attain primary implant stability following immediate implant placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Implant primary stability | 12 months after implant placement | Implant primary stability was assessed using Resonance Frequency Analysis at baseline and at 3, 6, and 12 months after implant placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue change of modified Plaque Iindex | 12 months after implant placement | Soft tissue change of modified Plaque Iindex (mPI) was done at baseline and 3, 6 and 12 months after implant placement |
| Soft tissue change of modified sulcus bleeding index | 12 months after implant placement | Soft tissue change of modified sulcus bleeding index was done at baseline and 3, 6 and 12 months after implant placement |
| Soft tissue change of peri-implant probing depth | 12 months after implant placement | Soft tissue change of peri-implant probing depth (PPD) was done at baseline and 3, 6 and 12 months after implant placement |
| Radiographic Evaluation to horizontal jumping gap | 12 months after implant insertion | Radiographic Evaluation to horizontal jumping gap using CBCT was done at baseline and 6 and 12 months after implant insertion |
| Radiographic Evaluation to buccal bone thickness | 12 months after implant insertion | Radiographic Evaluation to buccal bone thickness using CBCT and vertical marginal bone level and bone density were done at baseline and 6 and 12 months after implant insertion |
| Biochemical assessment of peri-implant crevecular fluid level | 3 months after implant placement | Biochemical assessment of peri-implant crevecular fluid level of osteopontin by ELISA was done at basline,1week; and 3 months after implant placement. |
Countries
Egypt
Outcome results
None listed