NCT06028867

Brief Summary

Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 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

January 24, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

August 31, 2023

Last Update Submit

May 7, 2024

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Subgingival biofilm

    Subgingival biofilm collected with sterile paper strips and analyzed by polimerase chain reaction

    2 weeks

Study Arms (3)

Chlorhexidine 0,12% + Sodium DNA mouthwash

EXPERIMENTAL

Patients are treated with a mouthwash containing Chlorhexidine 0,12% + Sodium DNA

Procedure: Non-surgical periodontal treatment

Chlorhexidine 0,20% mouthwash

ACTIVE COMPARATOR

Patients are treated with a mouthwash containing Chlorhexidine 0,20%

Procedure: Non-surgical periodontal treatment

Placebo mouthwash

PLACEBO COMPARATOR

Patients are treated with a placebo mouthwash

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE

Subgingival biofilm ultrasonic debridement

Chlorhexidine 0,12% + Sodium DNA mouthwashChlorhexidine 0,20% mouthwashPlacebo mouthwash

Eligibility Criteria

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

You may qualify if:

  • Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.

You may not qualify if:

  • Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
  • Pregnancy.
  • Systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Sealed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 8, 2023

Study Start

January 24, 2020

Primary Completion

January 30, 2024

Study Completion

April 20, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)