The comparison of flap and flapless technique of placing mini implants supporting mandibular over denture on crestal bone loss in diabetic individuals- A randomised control trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- flapless surgical technique is effective in reducing the crestal bone loss around mini implant supported overdenture among completely edentulous controlled Type 2 diabetic patients.
Study Overview
Brief Summary
Completely edentulous patients using removable complete denture often suffer from lack of retention and stability of dentures. Solution for this is rehabilitation with dental implants. Diabetes Mellitus is a metabolic disorder and considered a relative risk for dental implant therapy. As there is delayed wound and bone healing and compromised immunity among diabetic patients, many of them are denied the benefits of dental implant therapy. Traditional surgical implant placement protocol uses a full thickness mucoperiosteal flap, which might lead to initiation of crestal bone loss and may be a contributory factor for implant failure among diabetic patients. Studies have shown that a flapless approach for implant placement has a positive effect on crestal bone remodelling as well as added effects of better soft and hard tissue healing and patient comfort. Also, the dimension of mini implant further simplifies the process.
So, this study aims to To assess and compare the bone loss around mini-implant retained overdenture placed by full thickness flap versus flapless surgery in the mandibular arch among controlled Type 2 Diabetic patients utilizing 3-dimensional Cone Beam Computed Tomography.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects with completely edentulous maxillary and mandibular arches.
- •Glycosylated haemoglobin (HbA1c) levels 6.1–8 %.
- •Extraction site healed for at least 12 weeks.
- •Adequate bone width and height to place an implant of at least 2.4 mm diameter and 10 mm length.
Exclusion Criteria
- •Subjects requiring bone augmentation procedure.
- •before or during implant placement.
- •Microvascular complications such as nephropathy, neuropathy and retinopathy.
- •Habit of smoking, pan chewing and chronic alcoholism.
- •Pre-cancerous lesions and conditions.
- •medical contra indication for implant surgery.
- •Severe bony defects in the implantation site.
- •Poor neuromuscular control.
- •Severe prognathism or retrognathism of jaws.
Outcomes
Primary Outcomes
flapless surgical technique is effective in reducing the crestal bone loss around mini implant supported overdenture among completely edentulous controlled Type 2 diabetic patients.
Time Frame: 9months
Secondary Outcomes
- Flapless surgical technique is effective in reducing bone loss around dental implants.(9 months)