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.

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. - Perisolv

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006977

Enrollment

Registered

2017-11-06

Start date

2015-10-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant inflammation

Interventions

Group 1: Non-surgical mechanical debridement associated at local biochemical agent (hypochlorite and amino acids in low doses) in the treatment of peri-implant mucositis. Group 2: Non-surgical mechani

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

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;

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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; 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; 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.	—

Measure

Time frame

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; 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; 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.

—

Countries

Italy

Contacts

Public ContactVincenzo Iorio-Siciliano

Department of Periodontology University of Naples Federico II

enzois@libero.it00390818845462

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026