Periodontal Gel in NSPT

April 16, 2026 updated by: Fabrizio Guerra, University of Roma La Sapienza

Use of Periodontal Gel in Non-Surgical Periodontal Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective case series included patients diagnosed with stage II/III periodontitis, aged between 30 and 70 years, treated from May 2022 to September 2024. Patients were selected according to specific inclusion and exclusion criteria and provided informed consent. At baseline (T0), all subjects underwent a comprehensive periodontal examination, including full-mouth periodontal charting and radiographic assessment, with recording of clinical parameters such as probing depth (PD), clinical attachment level (CAL), bleeding on probing (BoP), and plaque index (PI).

All patients received non-surgical periodontal therapy through scaling and root planing using both manual curettes and ultrasonic instruments, following a full-mouth disinfection protocol. At the end of treatment, a postbiotic periodontal gel was prescribed for home use twice daily for 10 days, together with a toothpaste of the same formulation. Oral hygiene instructions were reinforced during follow-up, and clinical parameters were re-evaluated after 8 weeks (T1). Additionally, a questionnaire was administered to assess patient-reported outcomes regarding symptoms and treatment satisfaction.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00161
        • Sapienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Periodontal Gel + NSPT
Adjunctive use of a gel after NSPT
Other: Periodontal Gel as an Adjunct to NSPT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: From enrollment to the end of treatment at 8 weeks
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)
Time Frame: From enrollment to the end of treatment at 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full Mouth Bleeding Score (FMBS)
Time Frame: From enrollment to the end of treatment at 8 weeks
Full Mouth Bleeding Score (FMBS), expressed as the percentage (%) of sites exhibiting bleeding on probing out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate more gingival inflammation and a worse outcome.
From enrollment to the end of treatment at 8 weeks
Full Mouth Plaque Score (FMPS)
Time Frame: From enrollment to the end of treatment at 8 weeks
Full Mouth Plaque Score (FMPS), expressed as the percentage (%) of sites with visible plaque out of the total number of sites examined. The scale ranges from 0% to 100%, where higher percentages indicate poorer oral hygiene and a worse outcome.
From enrollment to the end of treatment at 8 weeks
Patient Satisfaction (Questionnaire)
Time Frame: From enrollment to the end of treatment at 8 weeks
Patient satisfaction, assessed using a structured questionnaire evaluating comfort, perceived effectiveness, and overall satisfaction with the treatment. Each item is recorded as a dichotomous response (Yes/No). Responses are summarized as the percentage (%) of positive ("Yes") answers out of the total number of questions. The scale ranges from 0% to 100%, where higher percentages indicate greater patient satisfaction and a better outcome.
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1956/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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