Clinical trial NCT02789306: Preventive Maintenance Therapy on Peri-implant Diseases
Official title: Influence of Maintenance Therapy on Peri-implant Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periimplantitis
Periodontal Disease
Keywords: Preventive therapy
Dental implants
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
First posted: 2016-06-03
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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')

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of peri-implantitis
timeFrame: 12 months
Secondary outcomes:
measure: Compliance of patients
timeFrame: 12 months
measure: Local and systemic factors on peri-implantitis
timeFrame: 12 months
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Florencio Monje Gil
Study officials:
References:
citation: 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.
citation: 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.