NCT05558293

Brief Summary

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth periodontal debridement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 23, 2022

Last Update Submit

November 8, 2023

Conditions

Periodontitis

Keywords

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Probing depth changes

    Measurment of Probing Depth changes in millimeters

    6 months

Study Arms (2)

Periodontitis quadrant Scaling root planing

PLACEBO COMPARATOR

Patients undergo non surgical quadrant scaling and root planing performed per quadrant

Procedure: Scaling and root planing

Periodontitis full mouth scaling root planing

ACTIVE COMPARATOR

Patients undergo non surgical full mouth scaling and root planing

Procedure: Scaling and root planing

Interventions

Scaling and root planingPROCEDURE

Full mouth or quadrant SRP

Periodontitis full mouth scaling root planingPeriodontitis quadrant Scaling root planing

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • good condition of general health,
  • a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
  • no involvement of the furcation,
  • a minimum of a six teeth per quadrant, respectively.

You may not qualify if:

  • periodontal therapy during the last 12 months,
  • assumption of antibiotics during the last 6 months,
  • pregnancy,
  • any systemic condition which might affect the effects of the study treatment,
  • previous or current radiation or immunosuppressive therapies,
  • use of mouthwash containing antimicrobials during the previous 3 months,
  • no use of hormonal contraceptives,
  • medication by anti-inflammatory and immunosuppressive drugs,
  • previous history of hard-drinking,
  • smoking,
  • class II and III tooth mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania

Catania, CT, 95124, Italy

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Gaetano Isola

    University of Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both participants and clinicians were blinded to group and treatment assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients undergo non-surgical quadrant scaling and root planing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

June 1, 2022

Primary Completion

December 5, 2022

Study Completion

December 5, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Sharing inflammatory results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months
Access Criteria
University website and pubmed

Locations

IT(1)