GingivitisGEM-CHX012NCT07088653
MicroRepair® ABX vs Chlorhexidine 0.12% in Gingivitis Patients
A study testing MicroRepair ABX mouthwash and Chlorhexidine 0.12% mouthwash in people with Gingivitis and Dental Plaque, run by University of Pavia at 1 site in Italy.
Trial summary
This randomized controlled clinical trial is designed to compare the adjunctive effects of two mouthwashes used after professional biofilm removal in patients with generalized plaque-induced gingivitis, a reversible inflammatory condition caused by dental plaque accumulation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis, Dental Plaque, Gingival Inflammation
- What is being tested?
- MicroRepair ABX mouthwash and Chlorhexidine 0.12% mouthwash
- 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
- 30 Aug 2025to 10 Mar 2026
- 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
- Adults aged between 18 and 70 years
- Presence of generalized plaque-induced gingivitis, defined by bleeding on probing (BoP) ≥30% in the absence of clinical attachment loss, with probing pocket depth ≤3 mm at ≥90% of sites
- At least 20 natural teeth
- Good general health (ASA I or II)
- Signed written informed consent
- Willingness to comply with study protocol and attend all follow-up visits
Who cannot join
- Periodontitis, defined as interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth
- Systemic conditions known to affect periodontal status, including diabetes mellitus and immunodeficiencies
- Antibiotic or anti-inflammatory therapy within the previous 3 months
- Professional dental prophylaxis within the previous 3 months
- Pregnancy or breastfeeding
- Known allergy to chlorhexidine or MicroRepair components
Show all 9Show fewer
- Use of orthodontic appliances or removable prostheses
- Smoking more than 10 cigarettes per day
- Participation in other clinical trials within the previous 6 months
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Clinical and Salivary aMMP-8 Evaluation of 0.12% Chlorhexidine Versus MicroRepair® ABX Mouthwash in the Non-Surgical Management of Plaque-Induced Gingivitis: A Randomized Controlled Trial
This randomized controlled clinical trial is designed to compare the adjunctive effects of two mouthwashes used after professional biofilm removal in patients with generalized plaque-induced gingivitis, a reversible inflammatory condition caused by dental plaque accumulation. The two interventions under investigation are a 0.12% chlorhexidine (CHX) mouthwash, commonly used as a reference antiseptic, and a MicroRepair® ABX mouthwash containing a multi-component antibacterial complex composed of cetylpyridinium chloride, magnolol, and honokiol, combined with biomimetic hydroxyapatite.
All participants will receive standardized professional oral hygiene treatment according to the Guided Biofilm Therapy (GBT) protocol. Following this procedure, participants will be randomly assigned to one of the two study groups and instructed to use the allocated mouthwash twice daily for 14 days as an adjunct to routine oral hygiene.
Read more
Clinical outcomes will include measures of gingival inflammation and plaque accumulation, such as Full-Mouth Bleeding Score (FMBS) and Full-Mouth Plaque Score (FMPS), along with additional periodontal parameters (probing pocket depth, clinical attachment level, and gingival recession). Treatment-related effects such as tooth staining and dentinal hypersensitivity will also be evaluated. A biological outcome will be assessed through the measurement of salivary levels of active matrix metalloproteinase-8 (aMMP-8), a biomarker associated with periodontal inflammation. Patient-reported outcomes, including perceptions of gingival condition, oral comfort, and taste acceptability, will also be collected.
Participants will be followed for 6 months. The study aims to determine whether the MicroRepair® ABX mouthwash provides clinical, biological, and patient-reported outcomes comparable to those of chlorhexidine when used as an adjunct to professional biofilm removal in the management of plaque-induced gingivitis.
Read the detailed description
Gingivitis is the most common reversible form of periodontal disease and is primarily caused by the accumulation of bacterial biofilm along the gingival margin. Chlorhexidine digluconate is widely used as an adjunct to professional oral hygiene; however, its use may be associated with adverse effects such as tooth staining, taste alteration, and mucosal irritation. In recent years, alternative formulations combining antibacterial agents and biomimetic hydroxyapatite have been investigated for their potential role in plaque control and gingival inflammation management.
This randomized, controlled, monocentric clinical trial aims to compare the clinical and biological effects of a mouthwash containing a multi-component antibacterial complex (MicroRepair® ABX), composed of cetylpyridinium chloride, magnolol, and honokiol combined with biomimetic hydroxyapatite, with those of a 0.12% chlorhexidine (CHX) mouthwash in patients with generalized plaque-induced gingivitis. Forty adult participants will be randomly assigned to receive professional oral hygiene followed by 14 days of adjunctive use of either the MicroRepair® ABX mouthwash or the 0.12% CHX mouthwash.
The primary endpoint is the reduction in gingival bleeding, assessed by the Full-Mouth Bleeding Score (FMBS). Secondary outcomes include changes in dental plaque accumulation (Full-Mouth Plaque Score, FMPS), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC), salivary levels of active matrix metalloproteinase-8 (aMMP-8), tooth staining assessed by the Modified Lobene Stain Index, dentinal hypersensitivity assessed by the Schiff Air Index, and patient-reported outcomes related to oral perception and tolerability.
Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months. This study is designed to evaluate whether the tested multi-component mouthwash provides clinical and biological outcomes comparable to those of chlorhexidine when used as an adjunct to professional oral hygiene in the management of plaque-induced gingivitis.
- Conditions
- Gingivitis, Dental Plaque, Gingival Inflammation
- Being tested
- MicroRepair ABX mouthwash, Chlorhexidine 0.12% mouthwash
- Keywords
- Chlorhexidine 0.12%, MicroRepair ABX, Gingivitis, Dental Plaque, Gingival Inflammation, Mouthwash, Oral Hygiene, Guided Biofilm Therapy, aMMP-8, Randomized Controlled Trial
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroRepair ABX mouthwashDrug
Also called MicroRepair® ABX
Participants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using MicroRepair® ABX mouthwash. The formulation contains zinc-hydroxyapatite with antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study.
Chlorhexidine 0.12% mouthwashDrug
Also called Chlorhexidine 0.12%
Participants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using 0.12% chlorhexidine (CHX) mouthwash. Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same SLS-free toothpaste (Biorepair®) throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| MicroRepair® ABX Mouthwash Group | Experimental | Participants assigned to the experimental group will undergo baseline clinical assessments (T0) followed by professional supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol. Standardized oral hygiene instructions will be provided.
Participants will then use a MicroRepair® ABX mouthwash, containing cetylpyridinium chloride, magnolol, honokiol, and biomimetic hydroxyapatite, twice daily for 14 days. Receives: Drug: MicroRepair ABX mouthwash |
| 0.12% Chlorhexidine Mouthwash Group | Active comparator | Participants assigned to the comparator group will undergo baseline clinical assessments (T0), followed by professional supragingival prophylaxis performed according to the Guided Biofilm Therapy (GBT) protocol, including plaque disclosure, ultrasonic instrumentation (EMS Piezon), and air polishing with glycine powder. Standardized oral hygiene instructions will be provided.
After this initial phase, participants will be instructed to use a 0.12% chlorhexidine (CHX) mouthwash twice daily for 14 days. Receives: Drug: Chlorhexidine 0.12% mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)
FMBS measures the percentage of bleeding sites after gentle probing at four sites per tooth (mesial, buccal, distal, lingual). It reflects the presence and severity of gingival inflammation. Scores range from 0% (no bleeding) to 100% (bleeding at all sites). A higher FMBS indicates more severe gingival inflammation. Comparison of FMBS over time will be used to assess clinical response to treatment.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Secondary outcomes (8)
Change in plaque accumulation assessed by Full Mouth Plaque Score (FMPS)
The Full Mouth Plaque Score (FMPS) quantifies the percentage of tooth surfaces with visible dental plaque, assessed after plaque disclosure at four sites per tooth (mesial, buccal, distal, lingual). The score is calculated as the number of plaque-positive sites divided by the total number of sites ×100. Scores range from 0% (no plaque) to 100% (plaque on all surfaces). Lower scores indicate better oral hygiene. FMPS will be compared between groups across time points.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)
Periodontal probing depth (PPD) is defined as the distance from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, measured in millimeters using a calibrated periodontal probe (Hu-Friedy PCP UNC 15). PPD is assessed at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual). For each participant, a mean PPD value is calculated at each time point. Typical scores range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket), with higher values indicating more severe periodontal inflammation or attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two intervention groups: MicroRepair® ABX mouthwash regimen versus 0.12% chlorhexidine (CHX) mouthwash regimen.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in clinical attachment level assessed by Clinical Attachment Level (CAL)
Clinical Attachment Level (CAL) is the distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, measured in millimeters at six sites per tooth with a calibrated periodontal probe (Hu-Friedy PCP UNC 15). Scores typically range from 0 mm (healthy attachment) to ≥7 mm (severe attachment loss). Higher values indicate more severe periodontal damage. CAL will be compared between groups across time points.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in gingival recession assessed by Recession (REC)
Gingival Recession (REC) is defined as the distance in millimeters between the cemento-enamel junction (CEJ) and the gingival margin, measured at six sites per tooth with a calibrated periodontal probe. Scores typically range from 0 mm (no recession) to ≥5 mm (advanced recession). Higher values indicate greater apical migration of the gingival margin. REC will be compared between groups across time points.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in extrinsic staining assessed by Modified Lobene Stain Index (MLSI)
The Modified Lobene Stain Index (MLSI) assesses extrinsic tooth staining on buccal and lingual/palatal surfaces. Each surface is scored for stain area and intensity, with total scores ranging from 0 (no stain) to 3 (severe stain). Higher scores indicate more pronounced extrinsic discoloration. Index scores will be compared between groups across time points.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in dentin hypersensitivity assessed by Schiff Air Index (SAI)
The Schiff Air Index (SAI) measures dentinal hypersensitivity in response to an air stimulus applied to the cervical area of the tooth. Scores range from 0 (no response) to 3 (painful response and request to stop). Higher scores indicate greater dentinal hypersensitivity. Scores will be compared between groups across time points.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels
Active matrix metalloproteinase-8 (aMMP-8) is a salivary biomarker of periodontal inflammation, measured with a commercial immunoenzymatic test (aMMP-8 Test®, Biomolecular Diagnostic). Results are expressed in nanograms per milliliter (ng/mL). Reference ranges: <8 ng/mL = no inflammation; 9-19 ng/mL = mild inflammation; ≥20 ng/mL = severe inflammation. aMMP-8 levels will be compared between groups from baseline (T0) to 2 weeks (T1).
Measured: Baseline (T0), 2 weeks (T1)
Change in taste perception assessed by a validated taste alteration questionnaire
Taste perception will be evaluated using a validated patient-reported questionnaire that explores the presence and severity of taste alterations (e.g., bitter, metallic, or unpleasant taste). Each item is scored on a 5-point Likert scale: 0 = no alteration, 1 = mild alteration, 2 = moderate alteration, 3 = severe alteration, 4 = very severe alteration. The total score reflects the degree of dysgeusia perceived by the patient. Mean scores will be compared between groups at each time point to assess tolerability of the mouthwashes.
Measured: 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Aug 2025
- Primary completion28 Feb 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- None (open label)
- 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, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088653
- Sponsor's protocol ID
- 2025-CHX0.12vsABX
- Acronym
- GEM-CHX012
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Salivary aMMP-8 Evaluation of 0.12% Chlorhexidine Versus MicroRepair® ABX Mouthwash in the Non-Surgical Management of Plaque-Induced Gingivitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07088653
- Acronym / sponsor ID
- GEM-CHX012 / 2025-CHX0.12vsABX
- Conditions
- Gingivitis, Dental Plaque, Gingival Inflammation
- Keywords
- Chlorhexidine 0.12%, MicroRepair ABX, Gingivitis, Dental Plaque, Gingival Inflammation, Mouthwash, Oral Hygiene, Guided Biofilm Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 28 Jul 2025 (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 is designed to compare the adjunctive effects of two mouthwashes used after professional biofilm removal in patients with generalized plaque-induced gingivitis, a reversible inflammatory condition caused by dental plaque accumulation. The two interventions under investigation are a 0.12% chlorhexidine (CHX) mouthwash, commonly used as a reference antiseptic, and a MicroRepair® ABX mouthwash containing a multi-component antibacterial complex composed of cetylpyridinium chloride, magnolol, and honokiol, combined with biomimetic hydroxyapatite.
All participants will receive standardized professional oral hygiene treatment according to the Guided Biofilm Therapy (GBT) protocol. Following this procedure, participants will be randomly assigned to one of the two study groups and instructed to use the allocated mouthwash twice daily for 14 days as an adjunct to routine oral hygiene.
Clinical outcomes will include measures of gingival inflammation and plaque accumulation, such as Full-Mouth Bleeding Score (FMBS) and Full-Mouth Plaque Score (FMPS), along with additional periodontal parameters (probing pocket depth, clinical attachment level, and gingival recession). Treatment-related effects such as tooth staining and dentinal hypersensitivity will also be evaluated. A biological outcome will be assessed through the measurement of salivary levels of active matrix metalloproteinase-8 (aMMP-8), a biomarker associated with periodontal inflammation. Patient-reported outcomes, including perceptions of gingival condition, oral comfort, and taste acceptability, will also be collected.
Participants will be followed for 6 months. The study aims to determine whether the MicroRepair® ABX mouthwash provides clinical, biological, and patient-reported outcomes comparable to those of chlorhexidine when used as an adjunct to professional biofilm removal in the management of plaque-induced gingivitis.
Detailed description
Gingivitis is the most common reversible form of periodontal disease and is primarily caused by the accumulation of bacterial biofilm along the gingival margin. Chlorhexidine digluconate is widely used as an adjunct to professional oral hygiene; however, its use may be associated with adverse effects such as tooth staining, taste alteration, and mucosal irritation. In recent years, alternative formulations combining antibacterial agents and biomimetic hydroxyapatite have been investigated for their potential role in plaque control and gingival inflammation management.
This randomized, controlled, monocentric clinical trial aims to compare the clinical and biological effects of a mouthwash containing a multi-component antibacterial complex (MicroRepair® ABX), composed of cetylpyridinium chloride, magnolol, and honokiol combined with biomimetic hydroxyapatite, with those of a 0.12% chlorhexidine (CHX) mouthwash in patients with generalized plaque-induced gingivitis. Forty adult participants will be randomly assigned to receive professional oral hygiene followed by 14 days of adjunctive use of either the MicroRepair® ABX mouthwash or the 0.12% CHX mouthwash.
The primary endpoint is the reduction in gingival bleeding, assessed by the Full-Mouth Bleeding Score (FMBS). Secondary outcomes include changes in dental plaque accumulation (Full-Mouth Plaque Score, FMPS), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC), salivary levels of active matrix metalloproteinase-8 (aMMP-8), tooth staining assessed by the Modified Lobene Stain Index, dentinal hypersensitivity assessed by the Schiff Air Index, and patient-reported outcomes related to oral perception and tolerability.
Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months. This study is designed to evaluate whether the tested multi-component mouthwash provides clinical and biological outcomes comparable to those of chlorhexidine when used as an adjunct to professional oral hygiene in the management of plaque-induced gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroRepair® ABX Mouthwash Group | Experimental | Drug: MicroRepair ABX mouthwashParticipants assigned to the experimental group will undergo baseline clinical assessments (T0) followed by professional supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol. Standardized oral hygiene instructions will be provided. Participants will then use a MicroRepair® ABX mouthwash, containing cetylpyridinium chloride, magnolol, honokiol, and biomimetic hydroxyapatite, twice daily for 14 days. |
| 0.12% Chlorhexidine Mouthwash Group | Active comparator | Drug: Chlorhexidine 0.12% mouthwashParticipants assigned to the comparator group will undergo baseline clinical assessments (T0), followed by professional supragingival prophylaxis performed according to the Guided Biofilm Therapy (GBT) protocol, including plaque disclosure, ultrasonic instrumentation (EMS Piezon), and air polishing with glycine powder. Standardized oral hygiene instructions will be provided. After this initial phase, participants will be instructed to use a 0.12% chlorhexidine (CHX) mouthwash twice daily for 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 70 years
- Presence of generalized plaque-induced gingivitis, defined by bleeding on probing (BoP) ≥30% in the absence of clinical attachment loss, with probing pocket depth ≤3 mm at ≥90% of sites
- At least 20 natural teeth
- Good general health (ASA I or II)
- Signed written informed consent
Key exclusion criteria (9 listed)
- Periodontitis, defined as interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth
- Systemic conditions known to affect periodontal status, including diabetes mellitus and immunodeficiencies
- Antibiotic or anti-inflammatory therapy within the previous 3 months
- Professional dental prophylaxis within the previous 3 months
- Pregnancy or breastfeeding
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 |
|---|---|---|
| MicroRepair ABX mouthwashAlso: MicroRepair® ABXParticipants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using MicroRepair® ABX mouthwash. The formulation contains zinc-hydroxyapatite with antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study. | Drug | MicroRepair® ABX Mouthwash Group |
| Chlorhexidine 0.12% mouthwashAlso: Chlorhexidine 0.12%Participants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using 0.12% chlorhexidine (CHX) mouthwash. Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same SLS-free toothpaste (Biorepair®) throughout the study. | Drug | 0.12% Chlorhexidine Mouthwash Group |
Primary outcome
Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
FMBS measures the percentage of bleeding sites after gentle probing at four sites per tooth (mesial, buccal, distal, lingual). It reflects the presence and severity of gingival inflammation. Scores range from 0% (no bleeding) to 100% (bleeding at all sites). A higher FMBS indicates more severe gingival inflammation. Comparison of FMBS over time will be used to assess clinical response to treatment.
8 secondary outcomes
Change in plaque accumulation assessed by Full Mouth Plaque Score (FMPS)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in clinical attachment level assessed by Clinical Attachment Level (CAL)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in gingival recession assessed by Recession (REC)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in extrinsic staining assessed by Modified Lobene Stain Index (MLSI)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in dentin hypersensitivity assessed by Schiff Air Index (SAI)
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels
Time frame: Baseline (T0), 2 weeks (T1)
Change in taste perception assessed by a validated taste alteration questionnaire
Time frame: 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
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 23 Apr 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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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.
Andrea Scribante, Associate Professor 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 MicroRepair ABX mouthwash and Chlorhexidine 0.12% mouthwash in people with Gingivitis and Dental Plaque, 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 6 inclusion and 9 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 23 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?
Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS) (time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)). 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 23 Apr 2026.