Non Surgical Peri-implant Mucositis Treatment in Patients With Tissue-level and Bone-level Implants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04751565

Enrollment

Registered

2021-02-12

Start date

2021-02-01

Completion date

2021-12-20

Last updated

2023-02-28

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

Conditions

Peri-implant Mucositis

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.

Interventions

OTHERBleeding on Probing change reduction following peri-implant mucositis non surgical therapy

Statistically significant different in terms of Bleeding on Probing will be recorded between groups.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Intervention model description

Compare resolution of inflammation of naturally-occurring peri-implant mucositis (PM) at tissue-level (TL) and bone-level (BL) implants after non-surgical mechanical debridement.

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Bleeding on Probing (BOP) changes	Baseline (T0), 3-months (T1) and at 6-months (T2)	Changes over time in BOP changes (percentage)

Secondary

Measure	Time frame	Description
Full mouth plaque score (FMPS) changes	Baseline (T0), 3-months (T1) and at 6-months (T2)	Chenges in Full mouth plaque score (FMPS) (parameter)

Other

Measure	Time frame	Description
Pocket probing depth (PD) mm changes	Baseline (T0), 3-months (T1) and at 6-months (T2)	changes in Pocket probing depth (PD)
Presence of plaque at implant sites according to plaque index (PlI)	Baseline (T0), 3-months (T1) and at 6-months (T2)	Changes in presence of plaque at implant sites according to plaque index (PlI)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026