Clinical Trials Directory

Trials / Completed

CompletedNCT05574218

Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis

Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Universidad Complutense de Madrid · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGlycine air powderEvery 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with glycine powder air-polishing.
PROCEDURERubber cup polishingEvery 3 months, ultrasonic instrumentation was carried out with an specific implant tip coated with Polyether Ether Ketone (PEEK), activated subgingivally and circumferentially around the implant. Then, the implants were treated with rubber cup and a polishing paste.

Timeline

Start date
2013-01-01
Primary completion
2021-08-01
Completion
2021-08-01
First posted
2022-10-10
Last updated
2022-10-10

Source: ClinicalTrials.gov record NCT05574218. Inclusion in this directory is not an endorsement.