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Completed

NCT Number: NCT07534449

Periodontal Gel in NSPT

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.

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Key information

Conditions

Parodontitis Dry Socket Mouth Diseases Stomatognathic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza

Roma, RM, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periodontal Gel as an Adjunct to NSPT

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Use of Periodontal Gel in Non-Surgical Periodontal Therapy

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 16, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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