ClinicalTrials.gg
CompletedNCT07534449Updated Apr 20, 2026

Periodontal Gel in NSPT

An interventional study of Periodontal Gel as an Adjunct to NSPT in Parodontitis, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled May 2022, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parodontitis

Browse trials for

Keywords

  • NSPT
  • root planing
  • scaling
  • periodontal gel
03

In context

Dry Socket

46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 41 interventional studies indexed under Dry Socket.

Browse Dry Socket studies →

Lead sponsor

University of Roma La Sapienza is the lead sponsor of 398 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with Stage I or Stage IV periodontal disease
  • Current heavy smokers (≥10 cigarettes/day)
  • > 7%
  • ASA > III
  • Patients alredy using the study products
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Periodontal Gel + NSPT

    Adjunctive use of a gel after NSPT

    Other: Periodontal Gel as an Adjunct to NSPT

Interventions

  • OtherPeriodontal 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Full Mouth Bleeding Score (FMBS)

    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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. Full Mouth Plaque Score (FMPS)

    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.

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. Patient Satisfaction (Questionnaire)

    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.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 site
  • Sapienza
    Roma, RM 00161, Italy
08

References and documents

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.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2022 to primary completion in Nov 2024, 30 months.

Of 22 interventional studies with no phase under Dry Socket, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 30 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2026
First posted
Apr 16, 2026
StartActual
May 1, 2022
Primary completionActual
Nov 1, 2024
CompletionActual
Mar 1, 2025
Last update
Apr 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07534449
Responsible party
Fabrizio Guerra (Associate professor, MD, pHd, University of Roma La Sapienza) — Principal investigator
First posted
Apr 16, 2026
Start date
May 1, 2022
Primary completion
Nov 1, 2024
Completion
Mar 1, 2025
Last update
Apr 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion