Clinical trial NCT05574218: Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis
Official title: Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Detailed description: Study design:

This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).

Interventions:

At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss \>2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
* Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
* In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.

Exclusion Criteria:

* Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
* Patients requiring antibiotic prophylaxis.
* Heavy smokers (\> 10 cigarettes/day).
* Pregnant or lactating women

Primary outcomes:
measure: Probing Pocket Depth
timeFrame: Baseline, 6 and 18 months after the surgical procedure
Secondary outcomes:
measure: Distance of Gingival Recession
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Bleeding on Probing index
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Plaque Index
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Suppuration Index
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Concentration of the selected cytokines measured in pg/ml (IL1B; Il-6; IL-8; Tumoral Necrosis Factor Alpha)
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Presence of putative periodontal pathogens
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Frequency of detection of putative periodontal pathogens
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Proportions of putative periodontal pathogens
timeFrame: Baseline, 6 and 18 months after the surgical procedure
measure: Counts of putative periodontal pathogens
timeFrame: Baseline, 6 and 18 months after the surgical procedure
Other outcomes:
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