Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous

June 19, 2023 updated by: Gaetano Isola, University of Catania

Impact of Non-surgical Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous on a Single Tooth Restoration

The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study was to test the hypothesis that non-surgical periodontal therapy on peri-implant mucositis resolution results in a greater clinical improvement in patients with congruous versus non-congruous single dental implant restoration by comparing two groups of patients with peri-implant mucositis.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Catania, Italy, 95124
        • Recruiting
        • AOU Policlinico G. Rodolico
        • Contact:
          • Gaetano Isola, DDS
          • Phone Number: +3909537800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • peri-implant mucositis
  • bleeding on probing and/or a gingival index <1 at least at one site at baseline
  • absence of peri-implant bone loss during the last 2 years before baseline

Exclusion Criteria:

  • Periodontal disease
  • Systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Un-congruous single tooth peri implantitis
Patients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution
Other: Changes in Probing Depth to non-surgical periodontal therapy
Changes in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips
Placebo Comparator: Congruous single tooth peri implantitis
Patients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution
Other: Changes in Probing Depth to non-surgical periodontal therapy
Changes in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing change % reduction
Time Frame: 6-months
Reduction in bleeding on probing % change following non surgical periodontal therapy
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of probing depth in mm
Time Frame: 6-months
Reduction of probing depth following non surgical periodontal therapy
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Investigators

  • Principal Investigator: Gaetano Isola, Università degli Studi di Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-150-PO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study results

IPD Sharing Time Frame

1-year

IPD Sharing Access Criteria

Pubmed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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