---
title: Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants
nct_id: NCT04751565
overall_status: COMPLETED
phase: NA
sponsor: University of Messina
study_type: INTERVENTIONAL
primary_condition: Peri-implant Mucositis
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04751565.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04751565"
ct_last_update_post_date: 2023-02-28
last_seen_at: "2026-05-12T06:31:37.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

**Official Title:** Analysis of the Treatment of Non-surgical Peri-implant Mucositis Treatment in Patients With Tissue-level (TL) and Bone-level (BL) Implants

**NCT ID:** [NCT04751565](https://clinicaltrials.gov/study/NCT04751565)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 54
- **Lead Sponsor:** University of Messina
- **Conditions:** Peri-implant Mucositis
- **Start Date:** 2021-02-01
- **Completion Date:** 2021-12-20
- **CT.gov Last Update:** 2023-02-28

## Brief Summary

This study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

## Detailed Description

Group A: Peri-implant mucositis (PM) at tissue-level (TL) implants after non-surgical mechanical debridement.

Group B: Peri-implant mucositis (PM) bone-level (BL) implants after non-surgical mechanical debridement.

## Eligibility

- **Minimum age:** 25 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion criteria:

* Male and female aged \> 18 years
* TL and BL titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with PM (Berglundh, et al.,2018)
* Implants placed in both arches
* Patients with gingivitis or treated periodontitis (i.e., absence of residual PD \> 5 mm)
* Presence of at least 2 mm of keratinized mucosa at implant sites.

Exclusion criteria:

* presence of medical conditions contraindicating treatment of peri-implant mucositis,
* regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment

  * Presence of systemic diseases
  * Pregnant and lactating females
  * Smokers \> 10 cigarettes/day
  * Use of inflammatory drugs or antibiotics within 3 months prior to study recruitment
  * Implants with modified (i.e. micro-rough) necks
  * Interproximal open contacts between implant restoration and adjacent teeth
  * Peri-implantitis (Renvert, et al., 2018)
```

## Arms

- **Tissue level implant Group** (EXPERIMENTAL) — Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with tissue level implant

Primary outcome

The primary outcome will be based on probing depth (PD)
- **Bone level implant Group** (EXPERIMENTAL) — Evaluation of healing of peri-implant mucositis after non-surgical supra and subgingival debridement in patients with bone level implant

Primary outcome

The primary outcome will be the change in Bleeding on Probing (BOP) (Lang, Joss, Orsanic, Gusberti, Siegrist, 1986).

## Interventions

- **Bleeding on Probing change reduction following peri-implant mucositis non surgical therapy** (OTHER) — Statistically significant different in terms of Bleeding on Probing will be recorded between groups.

## Primary Outcomes

- **Bleeding on Probing (BOP) changes** _(time frame: Baseline (T0), 3-months (T1) and at 6-months (T2))_ — Changes over time in BOP changes (percentage)

## Secondary Outcomes

- **Full mouth plaque score (FMPS) changes** _(time frame: Baseline (T0), 3-months (T1) and at 6-months (T2))_

## Locations (1)

- University of Messina, Messina, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of messina|messina||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04751565.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04751565*  
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