TREATMENT OF PERI-IMPLANT MUCOSITIS USING A COMBINATION OF A NON-SURGICAL MECHANICAL DEBRIDEMENT AND LOCAL BIOCHEMICAL AGENT (PERISOLV®)RESPECT TO NON-SURGICAL MECHANICAL DEBRIDEMENT AND PLACEBO. A RANDOMIZED CONTROLLED CLINICAL TRIAL.

Phase 4

• Conditions: Peri-implant inflammation

• Registration Number: DRKS00006977
• Lead Sponsor: Department of Periodontology,University of Naples Federico II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-15
• Study Start: 2017-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Age = 18 years;
2. Male and female;
3. Periodontally health patients (PHP) and periodontally compromised patients (PCP);
4. Peri-implant mucositis ;
5. Submerged and non-submerged implants;
6. Implant supported single crowns;
7. Implant supported fixed partial dentures;
8. Implant supported fixed partial dentures with mesial or distal extension;
9. Implant supported full-arch bridges;
10. Tobacco smokers and non smokers.

Exclusion Criteria

1. Presence of relevant medical condition contraindicating surgical intervention;
2. Use of anti-inflammatory prescription medications or antibiotics within the preceding 3 months or during the study;
3. Pregnant or lactating females;
4. Implants supported overdenture or Toronto Bridges
5. Screw retained;
6. Implants without prosthesis reconstruction;
7. Peri-implantitis;

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is based on peri-implant probing depth (PD), assessed at baseline and at 6-month follow-up using a periodontal probe.

Secondary Outcome Measures

Name	Time	Method
1. Presence of plaque will be evaluated according to criteria of Plaque Index (PlI ; Silness & Löe 1964 ) and Plaque Index adapted for oral implants (mPI; Mombelli et al. 1987) and is are assessed at baseline and at 6-months follow-up;<br>2. The peri-implant mucosal and gingival tissue conditions will be evaluated using the criteria for Gingival Index (GI; Löe & Silness 1963) and Gingival Index adapted for oral implants (mBI; Mombelli et al 1987) and are are assessed at baseline and at 6-months follow-up;<br>3. The recession ( REC) will be measured from the implant shoulder to the peri-implant mucosal margin and is are assessed at baseline and at 6-months follow-up.<br>