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

NCT05574218 | Completed

• 1 other identifier: EMS/MTO
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth

  Changes in Probing Pocket Depth measured in milimeters with a manual periodontal probe

  Baseline, 6 and 18 months after the surgical procedure

Secondary Outcomes (10)

• Distance of Gingival Recession

  Baseline, 6 and 18 months after the surgical procedure

• Bleeding on Probing index

  Baseline, 6 and 18 months after the surgical procedure

• Plaque Index

  Baseline, 6 and 18 months after the surgical procedure

• Suppuration Index

  Baseline, 6 and 18 months after the surgical procedure

• Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect

  Baseline, 6 and 18 months after the surgical procedure

Study Arms (2)

Glycine - Test

EXPERIMENTAL

Polishing treatment with glycine powder air-polishing after ultrasonic plaque debridement.

Procedure: Glycine air powder

Rubber cup - Control

ACTIVE COMPARATOR

Polishing treatment with a rubber cup and polishing paste after ultrasonic debridement

Procedure: Rubber cup polishing

Interventions

Glycine air powder PROCEDURE

Every 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.

Glycine - Test

Rubber cup polishing PROCEDURE

Every 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.

Rubber cup - Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 10, 2022
• Study Start: January 1, 2013
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share