NCT05923554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

May 26, 2023

Last Update Submit

June 19, 2023

Conditions

Bleeding of Subgingival Space

Outcome Measures

Primary Outcomes (1)

  • Bleeding on probing change % reduction

    Reduction in bleeding on probing % change following non surgical periodontal therapy

    6-months

Secondary Outcomes (1)

  • Reduction of probing depth in mm

    6-months

Study Arms (2)

Un-congruous single tooth peri implantitis

ACTIVE COMPARATOR

Patients were treated through non-surgical periodontal treatment for the peri-implant mucositis resolution

Other: Changes in Probing Depth to non-surgical periodontal therapy

Congruous single tooth peri implantitis

PLACEBO COMPARATOR

Patients were treated through non-surgical periodontal treatment for the peri implant mucositis resolution

Other: Changes in Probing Depth to non-surgical periodontal therapy

Interventions

Changes in Probing Depth to non-surgical periodontal therapyOTHER

Changes in Probing Depth following non surgical periodontal treatment performed with hand and ultrasonic tips

Congruous single tooth peri implantitisUn-congruous single tooth peri implantitis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Periodontal disease
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

Study Officials

  • Gaetano Isola

    Università degli Studi di Catania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano Isola

CONTACT

0953785652gaetano.isola@unict.it

Rosalia Leonardi

CONTACT

rleonardi@unict.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Doctor

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 28, 2023

Study Start

May 25, 2023

Primary Completion

October 30, 2023

Study Completion

October 31, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
1-year
Access Criteria
Pubmed

Locations

IT(1)