Surgical Treatment of Periimplantitis in Patients With Risk Factors

NCT03814434 | Unknown

• 1 other identifier: RiskFactorsSurgPeriimplantitis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

peri-implantitis; inflammation; Therapy

Outcome Measures

Primary Outcomes (1)

• Radiographic Bone height Gain

  Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment

  3 months

Secondary Outcomes (1)

• Periimplant Pocket probing depth

  3 months

Study Arms (4)

Smokers with Periimplantitis group

EXPERIMENTAL

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.

Procedure: Non-Surgical treatment; Procedure: Surgical Treatment

Type 2 Diabetes with Periimplantitis group

EXPERIMENTAL

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.

Procedure: Non-Surgical treatment; Procedure: Surgical Treatment

Chronic Periodontitis with Periimplantitis group

EXPERIMENTAL

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.

Procedure: Non-Surgical treatment; Procedure: Surgical Treatment

Control with Periimplantitis group

EXPERIMENTAL

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.

Procedure: Non-Surgical treatment; Procedure: Surgical Treatment

Interventions

Non-Surgical treatment PROCEDURE

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

Chronic Periodontitis with Periimplantitis group; Control with Periimplantitis group; Smokers with Periimplantitis group; Type 2 Diabetes with Periimplantitis group

Surgical Treatment PROCEDURE

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

Chronic Periodontitis with Periimplantitis group; Control with Periimplantitis group; Smokers with Periimplantitis group; Type 2 Diabetes with Periimplantitis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luiz Antonio Pugliesi Alves de Lima: lead

Study Sites (1)

Faculdade de Odontologia Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

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

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luiz A Lima, phd

CONTACT

+5511992228876; lapalima@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 24, 2019
• Study Start: May 28, 2018
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: March 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)