Surgical Treatment of Periimplantitis in Patients With Risk Factors

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03814434
• Other study ID #: RiskFactorsSurgPeriimplantitis
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: January 28, 2020

Study information

• Verified date: March 2019
• Source: University of Sao Paulo
• Contact: Luiz A Lima, phd
• Phone: +5511992228876
• Email: lapalima[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Non-Surgical treatment
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
• Surgical Treatment
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture

Locations

Country	Name	City	State
Brazil	Faculdade de Odontologia Universidade de Sao Paulo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Luiz Antonio Pugliesi Alves de Lima

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Bone height Gain	Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment	3 months
Secondary	Periimplant Pocket probing depth	Periimplant probing depth comparison to baseline 3 months after surgical treatment	3 months