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Surgical Treatment of Periimplantitis in Patients With Risk Factors

L

Luiz Antonio Pugliesi Alves de Lima

Status

Unknown

Conditions

Smoking, Cigarette
Type 2 Diabetes Mellitus
Periodontal Diseases
Peri-Implantitis

Treatments

Procedure: Surgical Treatment
Procedure: Non-Surgical treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03814434
RiskFactorsSurgPeriimplantitis

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 4 patient groups

Smokers with Periimplantitis group
Experimental group
Description:
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.
Treatment:
Procedure: Surgical Treatment
Procedure: Non-Surgical treatment
Type 2 Diabetes with Periimplantitis group
Experimental group
Description:
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.
Treatment:
Procedure: Surgical Treatment
Procedure: Non-Surgical treatment
Chronic Periodontitis with Periimplantitis group
Experimental group
Description:
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.
Treatment:
Procedure: Surgical Treatment
Procedure: Non-Surgical treatment
Control with Periimplantitis group
Experimental group
Description:
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.
Treatment:
Procedure: Surgical Treatment
Procedure: Non-Surgical treatment

Trial contacts and locations

1

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Central trial contact

Luiz A Lima, phd

Data sourced from clinicaltrials.gov

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