Preventive Maintenance Therapy on Peri-implant Diseases

NCT ID: NCT02789306

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-03-01

Brief Summary

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

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')

Conditions

Periimplantitis; Periodontal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Epidemiological study on the incidence of peri-implantitis

Intervention Type: PROCEDURE

Clinical and radiographic examination in the routine based protocol

Healthy

No signs of inflammation and otherwise no bone loss beyond the biological bone remodeling

Epidemiological study on the incidence of peri-implantitis

Intervention Type: PROCEDURE

Clinical and radiographic examination in the routine based protocol

Interventions

Epidemiological study on the incidence of peri-implantitis

Clinical and radiographic examination in the routine based protocol

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Alberto Monje

DDS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florencio Monje Gil

Badajoz, , Spain

Countries

Spain

References

Monje A, Aranda L, Diaz KT, Alarcon MA, Bagramian RA, Wang HL, Catena A. Impact of Maintenance Therapy for the Prevention of Peri-implant Diseases: A Systematic Review and Meta-analysis. J Dent Res. 2016 Apr;95(4):372-9. doi: 10.1177/0022034515622432. Epub 2015 Dec 23.

Reference Type: RESULT

PMID: 26701350 (View on PubMed)

Monje A, Wang HL, Nart J. Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study. J Periodontol. 2017 Oct;88(10):1030-1041. doi: 10.1902/jop.2017.170135. Epub 2017 May 26.

Reference Type: DERIVED

PMID: 28548886 (View on PubMed)

Other Identifiers

18002909

Identifier Type: -

Identifier Source: org_study_id