Periodontal DiseasesNCT05312606
Hyaluronic Gel vs Chlorhexidine in Periodontal Patients
A study testing Aftoral Oral gel and Unidea Chlorhexidine digluconate mouthwash 0.20% in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.
Trial summary
This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Aftoral Oral gel and Unidea Chlorhexidine digluconate mouthwash 0.20%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 4 Apr 2022to 5 Nov 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of periodontitis sites according to the 2017 World Workshop classification system
- absence of systemic, metabolic, or autoimmune diseases
- compliant patients
Who cannot join
- neurological, psychiatric, or mental disorders
- patients taking bisphosphonates within the last 12 months
- patients taking antibiotics during the study period
- pregnant or breastfeeding women
- patients undergoing anticancer treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Efficacy of a Hyaluronic Acid-Based Gel Versus 0.20% Chlorhexidine in Non-Surgical Periodontal Therapy: A Single-Blind Randomized Clinical Trial
This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy.
After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
Read more
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
Professional oral hygiene procedures will be repeated at T2 and T3.
At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
- Gingival Recession (GR)
- Probing Pocket Depth (PPD)
- Bleeding on Probing (BoP)
- Clinical Attachment Level (CAL)
- Plaque Control Record (PCR)
- Tooth Mobility (TM)
Read the detailed description
This is a randomized controlled clinical trial (RCT). A total of 40 patients with periodontitis are expected to be enrolled. After providing written informed consent, patients meeting the inclusion criteria will undergo supragingival and subgingival professional periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia (Italy).
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel, containing hyaluronic acid, xylitol and glycerophosphoinositol, applied as domiciliary treatment for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
Professional oral hygiene procedures will be repeated at T2 and T3.
At each follow-up visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
- Gingival Recession (GR)
- Probing Pocket Depth (PPD)
- Bleeding on Probing (BoP)
- Clinical Attachment Level (CAL)
- Plaque Control Record (PCR)
- Tooth Mobility (TM)
- Conditions
- Periodontal Diseases
- Being tested
- Aftoral Oral gel, Unidea Chlorhexidine digluconate mouthwash 0.20%
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aftoral Oral gelOther
Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).
Unidea Chlorhexidine digluconate mouthwash 0.20%Other
Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Home treatment with hyaluronic acid. Receives: Other: Aftoral Oral gel |
| Control Group | Active comparator | Home treatment with chlorhexidine. Receives: Other: Unidea Chlorhexidine digluconate mouthwash 0.20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Gingival Recession (R)
Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin.
Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Change in Bleeding on Probing (BOP%)
Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).
Formula = n ° bleeding sites / n ° probed sites x100
Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Change in Clinical Attachment Level (CAL)
Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites.
Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Change in Plaque Control Record (PCR%)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Formula = n ° sites with plaque / total n ° of dental surfaces x100
Measured: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start4 Apr 2022
- Primary completion1 Nov 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MS, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312606
- Sponsor's protocol ID
- 2022-AFTORAL PARO
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2022
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Hyaluronic Acid-Based Gel Versus 0.20% Chlorhexidine in Non-Surgical Periodontal Therapy: A Single-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05312606
- Acronym / sponsor ID
- 2022-AFTORAL PARO
- Conditions
- Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 5 Apr 2022 (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 randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy.
After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
Professional oral hygiene procedures will be repeated at T2 and T3.
At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
- Gingival Recession (GR)
- Probing Pocket Depth (PPD)
- Bleeding on Probing (BoP)
- Clinical Attachment Level (CAL)
- Plaque Control Record (PCR)
- Tooth Mobility (TM)
Detailed description
This is a randomized controlled clinical trial (RCT). A total of 40 patients with periodontitis are expected to be enrolled. After providing written informed consent, patients meeting the inclusion criteria will undergo supragingival and subgingival professional periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder.
All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia (Italy).
After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy:
- Aftoral® Oral Gel, containing hyaluronic acid, xylitol and glycerophosphoinositol, applied as domiciliary treatment for 15 days.
- Unidea® chlorhexidine digluconate mouthwash 0.20%, used as domiciliary rinse for 15 days.
The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3).
Professional oral hygiene procedures will be repeated at T2 and T3.
At each follow-up visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site:
- Gingival Recession (GR)
- Probing Pocket Depth (PPD)
- Bleeding on Probing (BoP)
- Clinical Attachment Level (CAL)
- Plaque Control Record (PCR)
- Tooth Mobility (TM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Aftoral Oral gelHome treatment with hyaluronic acid. |
| Control Group | Active comparator | Other: Unidea Chlorhexidine digluconate mouthwash 0.20%Home treatment with chlorhexidine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of periodontitis sites according to the 2017 World Workshop classification system
- absence of systemic, metabolic, or autoimmune diseases
- compliant patients
Key exclusion criteria (5 listed)
- neurological, psychiatric, or mental disorders
- patients taking bisphosphonates within the last 12 months
- patients taking antibiotics during the study period
- pregnant or breastfeeding women
- patients undergoing anticancer treatment
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 |
|---|---|---|
| Aftoral Oral gelPatients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application). | Other | Trial Group |
| Unidea Chlorhexidine digluconate mouthwash 0.20%Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application). | Other | Control Group |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Gingival Recession (R)
Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin.
Change in Bleeding on Probing (BOP%)
Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100
Change in Clinical Attachment Level (CAL)
Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites.
Change in Plaque Control Record (PCR%)
Time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100
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 25 Mar 2026.
- Individual participant dataSharing planned: No. Data are available upon motivated request to the Principal Investigator.
Related trials for Periodontal Diseases
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
Antibiotic Resistance Genes in Periodontitis
Periodontal Disease, Periodontitis
RecruitingObservational study
Candida Albicans in Syrian Patients With Periodontitis
Periodontal Disease, Periodontal Diseases
Recruiting
Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life
Periodontitis, Periodontal Diseases
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Andrea Scribante, DDS, PhD, MS principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aftoral Oral gel and Unidea Chlorhexidine digluconate mouthwash 0.20% in people with Periodontal Diseases, run by University of Pavia 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 25 Mar 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?
Change in Probing Pocket Depth (PPD) (time frame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.