Clinical trial NCT03814434: Surgical Treatment of Periimplantitis in Patients With Risk Factors
Official title: Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peri-Implantitis
Type 2 Diabetes Mellitus
Smoking, Cigarette
Periodontal Diseases
Keywords: peri-implantitis
inflammation
Therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is not a randomized study. All patients will entered the study after being diagnosed with periimplantitis. Patients will be allocated to different groups according to their condition: Heavy Smokers, Type 2 Diabetes Mellitus, Chronic periodontitis and systemically healthy patients (control group).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Radiographic Bone height Gain
timeFrame: 3 months
Secondary outcomes:
measure: Periimplant Pocket probing depth
timeFrame: 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia Universidade de Sao Paulo
state: Sao Paulo
Study officials:
References: