Surgical Treatment of Periimplantitis in Patients With Risk Factors

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Peri-Implantitis; Periodontal Diseases; Smoking, Cigarette
• Interventions: Procedure: Non-Surgical treatment; Procedure: Surgical Treatment

• Registration Number: NCT03814434
• Lead Sponsor: Luiz Antonio Pugliesi Alves de Lima

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.

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-11
• Primary Completion: 2020-01-28
• Study Completion: 2020-01-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control with Periimplantitis group	Non-Surgical treatment	Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Type 2 Diabetes with Periimplantitis group	Surgical Treatment	Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Chronic Periodontitis with Periimplantitis group	Surgical Treatment	Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Smokers with Periimplantitis group	Non-Surgical treatment	Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Type 2 Diabetes with Periimplantitis group	Non-Surgical treatment	Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Chronic Periodontitis with Periimplantitis group	Non-Surgical treatment	Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Smokers with Periimplantitis group	Surgical Treatment	Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
Control with Periimplantitis group	Surgical Treatment	Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.

Primary Outcome Measures

Name	Time	Method
Radiographic Bone height Gain	3 months	Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment

Secondary Outcome Measures

Name	Time	Method
Periimplant Pocket probing depth	3 months	Periimplant probing depth comparison to baseline 3 months after surgical treatment

Trial Locations

Locations (1)

Faculdade de Odontologia Universidade de Sao Paulo; 🇧🇷 São Paulo, Sao Paulo, Brazil