Preventive Maintenance Therapy on Peri-implant Diseases

NCT02789306 | Completed DMC

• 1 other identifier: 18002909
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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

Conditions

Periimplantitis; Periodontal Disease

Keywords

Preventive therapy; Dental implants

Outcome Measures

Primary Outcomes (1)

• Incidence of peri-implantitis

  * '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 Outcomes (2)

• Compliance of patients

  12 months

• Local and systemic factors on peri-implantitis

  12 months

Study Arms (2)

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

Healthy

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

Procedure: Epidemiological study on the incidence of peri-implantitis

Interventions

Epidemiological study on the incidence of peri-implantitis PROCEDURE

Clinical and radiographic examination in the routine based protocol

Healthy; Peri-implantitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Uncontrolled systemic diseases
• Implants because prosthetic characteristics can not be registered probing depth or attachment level appropriately
• Smoking\> 10 cigarettes a day
• Pregnant patients
• Implants not placed in our center

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead
• Universitat Internacional de Catalunya: collaborator

Study Sites (1)

Florencio Monje Gil

Badajoz, 06001, Spain

Location

Related Publications (2)

• 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.

  PMID: 26701350 RESULT

• 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.

  PMID: 28548886 DERIVED

MeSH Terms

Conditions

Peri-Implantitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 3, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

ES (1)