Back to resultsTreatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous
Primary Purpose
Bleeding of Subgingival Space
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Changes in Probing Depth to non-surgical periodontal therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding of Subgingival Space
Eligibility Criteria
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
Sites / Locations
- AOU Policlinico G. RodolicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Un-congruous single tooth peri implantitis
Congruous single tooth peri implantitis
Arm Description
Patients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution
Patients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution
Outcomes
Primary Outcome Measures
Bleeding on probing change % reduction
Reduction in bleeding on probing % change following non surgical periodontal therapy
Secondary Outcome Measures
Reduction of probing depth in mm
Reduction of probing depth following non surgical periodontal therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05923554
Brief Title
Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous
Official Title
Impact of Non-surgical Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous on a Single Tooth Restoration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding of Subgingival Space
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After non-randomization, patients were assigned to a group with un-congruous single-tooth prostheses and a group with congruous single-tooth prostheses. Patients received a one-stage full-mouth scaling without chlorhexidine. Clinical and microbiological examination was performed at baseline, after 1, 2, and 3 months.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Un-congruous single tooth peri implantitis
Arm Type
Active Comparator
Arm Description
Patients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution
Arm Title
Congruous single tooth peri implantitis
Arm Type
Placebo Comparator
Arm Description
Patients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution
Intervention Type
Other
Intervention Name(s)
Changes in Probing Depth to non-surgical periodontal therapy
Intervention Description
Changes in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips
Primary Outcome Measure Information:
Title
Bleeding on probing change % reduction
Description
Reduction in bleeding on probing % change following non surgical periodontal therapy
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Reduction of probing depth in mm
Description
Reduction of probing depth following non surgical periodontal therapy
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Isola
Phone
0953785652
Email
gaetano.isola@unict.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalia Leonardi
Email
rleonardi@unict.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola, DDS
Phone
+3909537800
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
1-year
IPD Sharing Access Criteria
Pubmed
Learn more about this trial
Treatment of Peri-implant Mucositis on Incongruous Dental Prostheses Versus Congruous
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