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Evaluation of two different approaches in mandibular edentulous type 2 diabetic patients rehabilitated through overdentures: 2-years outcomes of a split-mouth RCT.

Impact of different implant placement and connections on dental rehabilitation of type 2 diabetics through overdentures: Clinical, tomographic, microbiological and local biomarker profile evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4xz8sk
Enrollment
Unknown
Registered
2020-01-29
Start date
2014-10-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Diabetics type 2

Interventions

22 mandibular edentulous T2DM recommended for implant therapy were chosen and received 2 dental implants – Test Group: morse taper implant placed at subcrestal position with prosthetic intermediate of
Control Group: hexagon external implant placed at crestal level bone with prosthetic intermediate of diameter equal to the platform. Clinical, immunoenzymatic, and tomographic assays were carried out
D25.339.312

Sponsors

Universidade Paulista
Lead Sponsor
Universidade Paulista
Collaborator

Eligibility

Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients between 50 and 80 years old Edentulous mandible indicated for dental implant treatment tooth extractions that took place at least 06 months ago Patients with type 2 diabetes diagnosed for at least 05 years.

Exclusion criteria

Exclusion criteria: Pregnant patients, smokers or ex smokers, patients with systemic diseases that could alter bone metabolism, daily users of anti-inflammatory drugs, bisphosphonates, immunosuppressants, history of grafts in the area that would be operated, patients with severe complications due to diabetes such as for example cardiovascular disease, ulcers, gangrene, amputation, kidney disease and neuropathy.

Design outcomes

Primary

MeasureTime frame
Peri-implant bone crest difference between the test approach and the control approach. The test approach was expected to have less bone remodeling around the implant after function when compared to the control approach. The method used to verify the primary outcome was clinical evaluation in the parameters of probing depth, clinical attachment level, and position of the margem gingival and tomographic margin in linear measurements in millimeters. The variation of 0.6mm of the bone crest was adopted after 01 year as a parameter of analysis.;Concerning Probing depth and Clinical Attachment Level measurements, it was detected significantly higher means of these parameters in control implants when compared to test implants at baseline, 12 and 24 months No significant intra-group differences for PPD and Clinical attachment level throughout the investigation were observed. The values of Position Margem Gingival were not statistically different between experimental groups throughout the study. Annual bone loss changes in both groups. Augmented peri-implant bone loss was detected in the first year of implant loading when compared to the second year in both groups. Significantly higher peri-implant bone loss was observed in control implants in the first and second years in function when compared to test implants.

Secondary

MeasureTime frame
Positive modulation in the local inflammatory biomarkers found in the test treatment approach compared to the control approach. The method used for this analysis was the peri-implant fluid collection and the evaluation parameter was made through the quantification and qualification of these biomarkers through the Luminex Magpix platform.

Countries

Brazil

Contacts

Public ContactBruna Ghiraldini

Universidade Paulista

brunaghiraldini@yahoo.com.br+55-11-995415284

Outcome results

None listed

Source: REBEC (via WHO ICTRP)