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Surgical Treatment of Periimplantitis in Patients With Risk Factors

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03814434
Enrollment
40
Registered
2019-01-24
Start date
2018-05-28
Completion date
2020-01-28
Last updated
2019-03-11

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

Conditions

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

Keywords

peri-implantitis, inflammation, Therapy

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.

Interventions

Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation

PROCEDURESurgical Treatment

Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture

Sponsors

Luiz Antonio Pugliesi Alves de Lima
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Surgeon will not be aware of group being treated. Analyses of the data and statistics will not show explain what group has originated the data. Groups will be identified as A, B, C or D.

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Radiographic Bone height Gain3 monthsRadiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment

Secondary

MeasureTime frameDescription
Periimplant Pocket probing depth3 monthsPeriimplant probing depth comparison to baseline 3 months after surgical treatment

Countries

Brazil

Contacts

Primary ContactLuiz A Lima, phd
lapalima@usp.br+5511992228876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026