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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 (CBCT).

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036669
Enrollment
15
Registered
2021-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: Z40-Z53- Encounters for other specific health care Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Flapless technique: Dental implant placement by open flap technique followed by loading with denture after 3 months Control Intervention1: Open flap technique: Open flap technique of de

Sponsors

Akshatha D D
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with completely edentulous maxillary and mandibular arches. Glycosylated haemoglobin (HbA1c) levels 6.1ââ?¬â??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

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.

Design outcomes

Primary

MeasureTime frame
flapless surgical technique is effective in reducing the crestal bone loss around mini implant supported overdenture among completely edentulous controlled Type 2 diabetic patients.Timepoint: 9months—

Secondary

MeasureTime frame
Flapless surgical technique is effective in reducing bone loss around dental implants.Timepoint: 9 months—

Countries

India

Contacts

Public ContactDr Babashankara Alva M

Faculty of dental sciences of MSRUAS

babashankaralva@gmail.com9663115186

Outcome results

None listed

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