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OpenTrials
Completed

NCT Number: NCT04751565

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

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, 98100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. 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

  1. Full mouth plaque score (FMPS) changes

    Time frame: Baseline (T0), 3-months (T1) and at 6-months (T2)

    Chenges in Full mouth plaque score (FMPS) (parameter)

Other outcomes

  1. Pocket probing depth (PD) mm changes

    Time frame: Baseline (T0), 3-months (T1) and at 6-months (T2)

    changes in Pocket probing depth (PD)

  2. Presence of plaque at implant sites according to plaque index (PlI)

    Time frame: Baseline (T0), 3-months (T1) and at 6-months (T2)

    Changes in presence of plaque at implant sites according to plaque index (PlI)

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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