NCT07534449

Brief Summary

This retrospective case series included patients with stage II/III periodontitis treated with non-surgical periodontal therapy combined with a topical postbiotic gel. Clinical parameters (PD, CAL, BoP, PI) were recorded at baseline and after 8 weeks. Patients also applied the gel and a specific toothpaste at home, and outcomes were evaluated through clinical measurements and patient-reported feedback.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

May 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Periodontal DiseaseNSPTScaling and Root Planing

Outcome Measures

Primary Outcomes (2)

  • Probing depth

    Probing Depth (PD), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. PD represents the distance from the gingival margin to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate deeper periodontal pockets and a worse periodontal condition.

    From enrollment to the end of treatment at 8 weeks

  • Clinical Attachment Level (CAL)

    Clinical Attachment Level (CAL), measured in millimeters (mm) using a PCP 15 UNC periodontal probe. CAL represents the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket. The measurement range is from 0 to 15 mm. Higher values indicate greater attachment loss and a worse periodontal outcome.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (3)

  • Full Mouth Bleeding Score (FMBS)

    From enrollment to the end of treatment at 8 weeks

  • Full Mouth Plaque Score (FMPS)

    From enrollment to the end of treatment at 8 weeks

  • Patient Satisfaction (Questionnaire)

    From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Periodontal Gel + NSPT

EXPERIMENTAL

Adjunctive use of a gel after NSPT

Other: Periodontal Gel as an Adjunct to NSPT

Interventions

Immediately after NSPT all patients were instructed to pass the interdental brush with the gel in the interdental space and with the finger on the gums.

Periodontal Gel + NSPT

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Stage II and Stage III periodontal disease
  • Subjects aged between 30 and 70 years
  • Non-smokers or light smokers (\<10 cigarettes/day)

You may not qualify if:

  • Patients with Stage I or Stage IV periodontal disease
  • Current heavy smokers (≥10 cigarettes/day)
  • HbA1c \> 7%
  • ASA \> III
  • Patients alredy using the study products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza

Roma, RM, 00161, Italy

Location

Related Publications (1)

  • Butera, A. P. (2022). Domiciliary use of chlorhexidine vs. postbiotic gels in patients with peri-implant mucositis: a split-mouth randomized clinical trial. Applied Sciences.

    BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, pHd

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

May 1, 2022

Primary Completion

November 1, 2024

Study Completion

March 1, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations