Surgical Treatment of Periimplantitis in Patients With Risk Factors

March 7, 2019 updated by: Luiz Antonio Pugliesi Alves de Lima

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil
        • Recruiting
        • Faculdade de Odontologia Universidade de Sao Paulo
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Debora M Nomoto, DDS
        • Sub-Investigator:
          • Mauro A Murataka, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Smokers with Periimplantitis group
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
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
Procedure: Surgical Treatment
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
EXPERIMENTAL: Type 2 Diabetes with Periimplantitis group
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
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
Procedure: Surgical Treatment
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
EXPERIMENTAL: Chronic Periodontitis with Periimplantitis group
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
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
Procedure: Surgical Treatment
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
EXPERIMENTAL: Control with Periimplantitis group
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
Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
Procedure: Surgical Treatment
Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Bone height Gain
Time Frame: 3 months
Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periimplant Pocket probing depth
Time Frame: 3 months
Periimplant probing depth comparison to baseline 3 months after surgical treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luiz Antonio Pugliesi Alves de Lima

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2018

Primary Completion (ANTICIPATED)

January 28, 2020

Study Completion (ANTICIPATED)

January 28, 2020

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (ACTUAL)

January 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 7, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiskFactorsSurgPeriimplantitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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