ParodontitisNCT07534449
Periodontal Gel in NSPT
A study testing Periodontal Gel as an Adjunct to NSPT in people with Parodontitis, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Parodontitis
- What is being tested?
- Periodontal Gel as an Adjunct to NSPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage II and Stage III periodontal disease
- Subjects aged between 30 and 70 years
- Non-smokers or light smokers (<10 cigarettes/day)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Parodontitis
- Being tested
- Periodontal Gel as an Adjunct to NSPT
- Keywords
- NSPT, root planing, scaling, periodontal gel
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Gel as an Adjunct to NSPTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Gel + NSPT | Experimental | Adjunctive use of a gel after NSPT Receives: Other: Periodontal Gel as an Adjunct to NSPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
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.
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 May 2022
- Primary completion1 Nov 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534449
- Sponsor's protocol ID
- 1956/2024
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Periodontal Gel in Non-Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT07534449
- Acronym / sponsor ID
- 1956/2024
- Conditions
- Parodontitis
- Keywords
- NSPT, root planing, scaling, periodontal gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontal Gel + NSPT | Experimental | Other: Periodontal Gel as an Adjunct to NSPTAdjunctive use of a gel after NSPT |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Stage II and Stage III periodontal disease
- Subjects aged between 30 and 70 years
- Non-smokers or light smokers (<10 cigarettes/day)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal Gel as an Adjunct to NSPTImmediately 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. | Other | Periodontal Gel + NSPT |
Primary outcome
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.
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.
3 secondary outcomes
Full Mouth Bleeding Score (FMBS)
Time frame: 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
Patient Satisfaction (Questionnaire)
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- BackgroundButera, 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 dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal Gel as an Adjunct to NSPT in people with Parodontitis, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.