NCT05720481

Brief Summary

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

September 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

January 31, 2023

Last Update Submit

February 8, 2023

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • reduction of Growth differentiation factor-15 serum levels

    evaluation of serum Growth differentiation factor-15 change

    6 months

Study Arms (2)

Periodontitis quadrant Scaling root planing (SRP)

PLACEBO COMPARATOR

Each selected subject underwent to quadrant SRP

Other: Quadrant Scaling and root planing

Periodontitis full mouth scaling root planing (SRP)

ACTIVE COMPARATOR

Each selected subject underwent to full mouth SRP

Other: Full mouth Scaling and root planing

Interventions

Full mouth Scaling and root planingOTHER

patients were treated with full mouth Scaling and root planing

Periodontitis full mouth scaling root planing (SRP)
Quadrant Scaling and root planingOTHER

patients were treated with quadrant Scaling and root planing

Periodontitis quadrant Scaling root planing (SRP)

Eligibility Criteria

Age30 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
  • 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)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

Related Publications (1)

  • Isola G, Tartaglia GM, Santonocito S, Chaurasia A, Marya A, Lo Giudice A. Growth differentiation factor-15 and circulating biomarkers as predictors of periodontal treatment effects in patients with periodontitis: a randomized-controlled clinical trial. BMC Oral Health. 2023 Aug 21;23(1):582. doi: 10.1186/s12903-023-03237-y.

    PMID: 37605193DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental 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
Sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or Full-Mouth Scaling and Root Planing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

September 20, 2019

Primary Completion

September 30, 2022

Study Completion

October 15, 2022

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months
Access Criteria
Pubmed or internet

Locations

IT(1)