Preventive Maintenance Therapy on Peri-implant Diseases (PIMT)

April 24, 2017 updated by: Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Influence of Maintenance Therapy on Peri-implant Disease

In the field of periodontics, periodontal support therapy has proven to be essential in preventing the incidence or recurrence of periodontal diseases. The protocol is designed according to the risk profile of a patient. For example, in the presence of the history of periodontal therapy, subgingival microbiota containing large numbers of spirochetes and mobile rods can recolonize pockets 4-8 weeks after scaling. Similarly, routine maintenance of dental implants has been recommended to prudently avoid peri-implant inflammation, Indeed, the understanding of the nature of the tissue around the implant and its pattern of disease would be important to consider, even surpassing importance. Recently, a systematic review by our group has identified the importance of maintenance therapy around implants because it can help prevent about 3 times patient-level frequency peri-implantitis.

Henceforth, our primary goal was to study the influence in a cross-sectional study of the frequency of peri-implantitis patients according to their post-implant placement and corresponding prosthesis visits supportive peri-implant maintenance. As such, it will be shown:

  1. What are the local and systemic factors affecting the appearance of peri-implantitis
  2. The ideal frequency of supportive peri-implant maintenance in patients who do not develop peri-implant disease
  3. What is the population of patients who come to supportive peri-implant maintenance after placement of dental implants

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cross-sectional analysis that will include consecutive patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. a cross-sectional study calling patients to whom implants have placed them in two private practices (CICOM, Badajoz and Nart Clinica Dental, Barcelona, Spain) in the last 36 month to conduct clinical and radiographic study was performed. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.

- Clinical examination

A previously examiner (AN) calibrated perform all clinical measurements. The following clinical parameters were measured at six sites per implant (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual):

  1. Presence of plaque is recorded as 0 (no) or 1 (presence)
  2. Degree of gingival redness recorded as 0 (no) or 1 (presence)
  3. Depth bag measured from the gingival margin to the base of the bag in mm;
  4. clinical attachment level (CAL) by the number of exposed threads measured
  5. Bleeding on probing (BOP) recorded as 0 (no) or 1 (presence)
  6. Discharge is recorded as 0 (no) or 1 (presence)

  7. keratinized gingiva (mm)

    • Radiographic parameters A previously calibrated examiner perform radiographic measurement from the neck of the implant in the mesial and distal aspect of the implants using a digitized periapical. The software used for measurements will be ImageJ (approved by the American National Institute for Research - 'NIH')

Study Type

Observational

Enrollment (Actual)

115

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

  • Spain
      • Badajoz, Spain, 06001
        • Florencio Monje Gil

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cross-sectional analysis that will include patients with dental implants (> 250) with at least 36 months depending upon placement of the prosthesis. This procedure is justified because of the high frequency of peri-implant disease (30%) and since there is no predictable and effective treatment, only prevention can improve the success rate and functionality.

Description

Eligibility criteria:

  • Inclusion criteria

    1. Patients between 18 and 80 years old
    2. Consecutive patients that received dental implants in the last 36 months
    3. Patients with partial edentulism
    4. No antibiotic in the last 2 months
    5. Non-smoking or smoking <10 cigarettes a day

  • Exclusion Criteria

    1. Uncontrolled systemic diseases
    2. Implants because prosthetic characteristics can not be registered probing depth or attachment level appropriately
    3. Smoking> 10 cigarettes a day
    4. Pregnant patients
    5. Implants not placed in our center

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peri-implantitis

Peri-implantitis' - Loss radiographic bone beyond the biological bone remodeling at baseline (after prosthesis delivery) from the implant neck

  • Early:> 4 mm probing depth; <25% radiographic bone loss
  • Moderate:> 6mm probing depth; <50% radiographic bone loss
  • Severa:> 8 mm probing depth; > 50% radiographic bone loss
Procedure: Epidemiological study on the incidence of peri-implantitis
Clinical and radiographic examination in the routine based protocol
Healthy
No signs of inflammation and otherwise no bone loss beyond the biological bone remodeling
Procedure: Epidemiological study on the incidence of peri-implantitis
Clinical and radiographic examination in the routine based protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peri-implantitis
Time Frame: 12 months
  • 'Peri-implant health' - Absence of bleeding or inflammation
  • 'Peri-implant mucositis' - Presence of bleeding (inflammation) but without bone loss

  • 'Peri-implantitis' - Lost of radiographic bone from the implant neck

    • Early:> 4 mm probing depth; <25% radiographic bone loss
    • Moderate:> 6mm probing depth; <50% radiographic bone loss
    • Severe:> 8 mm probing depth; > 50% radiographic bone loss
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance of patients
Time Frame: 12 months
  • Every three months - 'compliers'
  • Every 6 months - 'compliers'
  • Between 6-12 months - 'erratic'
  • Sporadically - 'erratic'
  • Never after placement of restoration - 'non compliers'
12 months
Local and systemic factors on peri-implantitis
Time Frame: 12 months
  1. Sex (M / H)
  2. Age (years)

  3. Presence of periodontal disease in remaining teeth (determined by attachment level, probing depth, radiographic bone loss and presence of bleeding and / or discharge). By severity it will be stratified into 3 groups according to the 2015 American Academy of Periodontology (AAP):

    • Mild: Probing depth 3-5mm; bone loss <15%
    • Moderate: Probing depth: 5-7mm; 15-30% bone loss
    • Severe: Probing depth:> 7 mm; bone loss> 30%

By location it will be stratified into two groups:

  • Generalized:> 30%

  • Localized: <30%

    5. Diabetes (Yes / No - blood glucose level mg / dl) 6. History of periodontal disease (Yes / No) 7. Time from implant placement (always> 6months after restoration) 8. Location of the implant

  • Posterior maxilla (MP)
  • Anterior maxilla (MA)
  • Mandibular posterior (mp)
  • Mandibular anterior (ma)
12 months

Collaborators and Investigators

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

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Collaborators

Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18002909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Periodontal Disease

Clinical Trials on Epidemiological study on the incidence of peri-implantitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe