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Surgical Treatment of Periimplantitis in Patients With Risk Factors

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Non-Surgical treatment

Surgical Treatment

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring peri-implantitis, inflammation, Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Faculdade de Odontologia Universidade de Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Smokers with Periimplantitis group

Type 2 Diabetes with Periimplantitis group

Chronic Periodontitis with Periimplantitis group

Control with Periimplantitis group

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Radiographic Bone height Gain

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

Secondary Outcome Measures

Periimplant Pocket probing depth

Periimplant probing depth comparison to baseline 3 months after surgical treatment

Full Information

NCT ID

NCT03814434

First Posted

January 21, 2019

Last Updated

March 7, 2019

Sponsor

Luiz Antonio Pugliesi Alves de Lima

1. Study Identification

Unique Protocol Identification Number

NCT03814434

Brief Title

Surgical Treatment of Periimplantitis in Patients With Risk Factors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 28, 2018 (Actual)

Primary Completion Date

January 28, 2020 (Anticipated)

Study Completion Date

January 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Luiz Antonio Pugliesi Alves de Lima

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

peri-implantitis, inflammation, Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

InvestigatorOutcomes 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.

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Smokers with Periimplantitis group

Arm Type

Experimental

Arm Description

Arm Title

Type 2 Diabetes with Periimplantitis group

Arm Type

Experimental

Arm Description

Arm Title

Chronic Periodontitis with Periimplantitis group

Arm Type

Experimental

Arm Description

Arm Title

Control with Periimplantitis group

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Non-Surgical treatment

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgical Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Radiographic Bone height Gain

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Periimplant Pocket probing depth

Description

Periimplant probing depth comparison to baseline 3 months after surgical treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luiz A Lima, phd

Phone

+5511992228876

lapalima@usp.br

Facility Information:

Facility Name

Faculdade de Odontologia Universidade de Sao Paulo

City

São Paulo

State/Province

Sao Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luiz Lima, PhD

Phone

+551130917418

lapalima@usp.br

First Name & Middle Initial & Last Name & Degree

Daniela Y Takahashi, MSc

Phone

+551130917833

danyumietk@usp.br

First Name & Middle Initial & Last Name & Degree

Debora M Nomoto, DDS

First Name & Middle Initial & Last Name & Degree

Mauro A Murataka, DDS

12. IPD Sharing Statement

Plan to Share IPD

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Surgical Treatment of Periimplantitis in Patients With Risk Factors

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