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Clinical Trials/NCT03814434
NCT03814434
Unknown
Not Applicable

Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients

Luiz Antonio Pugliesi Alves de Lima1 site in 1 country40 target enrollmentMay 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peri-Implantitis
Sponsor
Luiz Antonio Pugliesi Alves de Lima
Enrollment
40
Locations
1
Primary Endpoint
Radiographic Bone height Gain
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates clinical and radiographic parameters among riks factor groups in patients with periimplantitis. This study will also treat and evaluate the patients response before and after surgical treatment.

Detailed Description

Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been recognized as potential risk factor indicators that might lead to complications establishment and progression around dental implants. PI treatment predictability has been shown limited and influenced by factors not totally clarified. The aim of this study is to evaluate the reparative response after PI surgical treatment at clinical and radiographic levelsin risk factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.

Registry
clinicaltrials.gov
Start Date
May 28, 2018
End Date
January 28, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Luiz Antonio Pugliesi Alves de Lima
Responsible Party
Sponsor Investigator
Principal Investigator

Luiz Antonio Pugliesi Alves de Lima

Associate Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Implants diagnosed with peri-implantitis with boné defects; Probing depth ≥ 4mm; Positive Bleeding on Probing and Suppuration score; Radiographic Bone Loss ≥ 3mm; Generalized Chronic Periodontitis (Armitage, 1999); Heavy Smokers (\> 10 cigarets per day); Type 2 Diabetes Mellitus tipo 2 (ADA, 2005) with HbA1c between 6.5% and 7.5%

Exclusion Criteria

  • Complete Edentulism; Mucosal disease; Alcohol abuse; Systemic disease except type 2 Diabetes Mellitus, that might interfere in periimplantitis progression; Medication intake: anticoagulants, antineoplasics, contraceptives, bisphosphonates and antidepressives; Medication intake in the last 6 months: antibiotics; Medication intake in the last 3 months: antiinflammatories; Aggressive Periodontitis and Anaphylactic shock history; Periodontal treatment in the last 6 months before the baseline; Periodontal Pockets \> 7mm; Light Smokers (\< 10 cigarets/day); Implant Mobility.

Outcomes

Primary Outcomes

Radiographic Bone height Gain

Time Frame: 3 months

Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment

Secondary Outcomes

  • Periimplant Pocket probing depth(3 months)

Study Sites (1)

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