Gingivitis and Periodontal DiseasesGEM-CHX02NCT07088666
0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis
A study testing MicroRepair ABX mouthwash and Chlorhexidine 0.2% mouthwash in people with Gingivitis and Periodontal Diseases and Dental Plaque, run by University of Pavia at 1 site in Italy.
Trial summary
Gingivitis is the most common form of reversible gum disease, caused by the accumulation of dental plaque. It leads to inflammation of the gums, bleeding, and discomfort, but it can be managed and reversed with professional dental cleaning and proper oral hygiene. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis and Periodontal Diseases, Dental Plaque, Oral Hygiene
- What is being tested?
- MicroRepair ABX mouthwash and Chlorhexidine 0.2% 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 (FMBS ≥ 25%, PPD ≤ 3 mm in ≥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 CAL ≥1 mm at ≥2 non-adjacent teeth)
- Systemic diseases affecting periodontal status (e.g., diabetes, immunodeficiencies)
- Antibiotic or anti-inflammatory therapy in the last 3 months
- Professional dental cleaning in the past 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 in the past 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: Comparison of 0.2% Chlorhexidine and MicroRepair ABX Mouthwash in Patients With Plaque-Induced Gingivitis: A Randomized Controlled Trial
Gingivitis is the most common form of reversible gum disease, caused by the accumulation of dental plaque. It leads to inflammation of the gums, bleeding, and discomfort, but it can be managed and reversed with professional dental cleaning and proper oral hygiene.
Chlorhexidine 0.2% mouthwash is considered the "gold standard" in reducing plaque and gingival inflammation. However, its long-term use may cause side effects such as tooth staining, changes in taste, and irritation of the oral tissues. MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals with antibacterial components, has shown promising properties in reducing plaque and supporting gum health, with potentially fewer side effects.
Read more
This randomized controlled clinical trial will compare the effectiveness of 0.2% chlorhexidine mouthwash and MicroRepair® ABX mouthwash, both used after professional dental cleaning, in patients with plaque-induced gingivitis. Forty participants will be randomly assigned to one of the two treatments for 14 days.
The primary outcome will be the change in gum pocket depth, measured as Probing Pocket Depth (PPD). Secondary outcomes include changes in plaque accumulation, measured as Full-Mouth Plaque Score (FMPS); gum bleeding, measured as Full-Mouth Bleeding Score (FMBS); attachment of the gums to the teeth, measured as Clinical Attachment Level (CAL); gum recession, measured as Recession (REC); tooth staining, measured with the Lobene Stain Index; tooth sensitivity, measured with the Schiff Air Index; taste alterations assessed through a validated questionnaire; and salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a biomarker of gum inflammation.
The goal of this study is to determine whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in treating plaque-induced gingivitis, while offering better tolerability and fewer side effects.
Read the detailed description
Gingivitis is a reversible inflammatory condition of the gums, caused by the accumulation of dental plaque. It is characterized by gum redness, swelling, and bleeding, but it does not involve loss of attachment or bone support. Although it can be effectively managed, untreated gingivitis may progress to periodontitis, which is a more severe and irreversible disease.
Chlorhexidine digluconate 0.2% is widely regarded as the gold standard among antiseptic mouthwashes because of its proven antibacterial and anti-plaque properties. Nevertheless, its long-term use is limited by adverse effects, including tooth and tongue staining, altered taste perception, and mucosal irritation. For this reason, alternative formulations with similar antibacterial potential but fewer side effects are under investigation.
MicroRepair® ABX mouthwash contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. Zinc-hydroxyapatite has shown the ability to reduce plaque accumulation, promote enamel remineralization, and support gum health without cytotoxic effects. Despite encouraging in vitro results and clinical studies in other conditions, there is still a lack of randomized controlled trials directly comparing MicroRepair® ABX with chlorhexidine 0.2% in patients with plaque-induced gingivitis.
This study aims to fill this gap by evaluating whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in reducing gingival inflammation after professional dental cleaning. In addition to standard clinical measures-such as Probing Pocket Depth (PPD), Full-Mouth Plaque Score (FMPS), Full-Mouth Bleeding Score (FMBS), Clinical Attachment Level (CAL), and Recession (REC)-the trial will also assess patient-related outcomes including tooth staining (Lobene Stain Index), dentinal sensitivity (Schiff Air Index), and taste alterations. Furthermore, salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a sensitive biomarker of periodontal inflammation, will be analyzed to provide insight into the biological mechanisms of action.
By integrating both clinical and biomolecular outcomes, this study will generate robust evidence on whether MicroRepair® ABX can serve as a safe and effective alternative to chlorhexidine 0.2% in the management of plaque-induced gingivitis.
- Being tested
- MicroRepair ABX mouthwash, Chlorhexidine 0.2% mouthwash
- Keywords
- Chlorhexidine 0.2%, MicroRepair ABX, Gingivitis, Plaque-induced gingivitis, Mouthwash, Oral hygiene, Dental plaque, aMMP-8, Periodontal health, Randomized controlled trial, Non-surgical periodontal therapy
- Medical subject headings
- Gingivitis, Periodontal Diseases, 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 Hydroxyapatite-based mouthwash
At baseline (T0), participants receive clinical assessments, oral hygiene instruction, and begin a 14-day home regimen with MicroRepair® ABX mouthwash, which contains zinc-hydroxyapatite microcrystals and antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). The mouthwash is used twice daily (10 mL for 30 seconds) after toothbrushing, without rinsing, and participants avoid food or drink for 1 hour. All participants use a sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study.
At 1 month (T1), participants undergo professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, ultrasonic debridement with an EMS Piezon piezoelectric device, and air-polishing with glycine powder.
At 3 months (T2) and 6 months (T3), additional GBT sessions and a repeated 14-day mouthwash cycle are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%.
Chlorhexidine 0.2% mouthwashDrug
Also called Chlorhexidine digluconate 0.2%
At baseline (T0), participants undergo clinical and photographic assessments, receive oral hygiene instruction, and begin a 14-day home regimen with 0.2% chlorhexidine digluconate mouthwash, used twice daily (10 mL for 30 seconds) after toothbrushing. The solution is not rinsed away, and participants avoid food or drink for 1 hour. All participants use a standardized sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®).
At 1 month (T1), participants receive professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, piezoelectric ultrasonic scaling with an EMS Piezon device, and air-polishing with glycine powder.
At 3 months (T2) and 6 months (T3), additional GBT sessions and repetition of the 14-day home regimen are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%.
| Study group | Role | What they receive |
|---|---|---|
| MicroRepair ABX Mouthwash | Experimental | Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour.
Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1. Receives: Drug: MicroRepair ABX mouthwash |
| 0.2% Chlorhexidine Mouthwash | Active comparator | Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use chlorhexidine digluconate 0.2% mouthwash, considered the gold standard for chemical plaque control. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour.
Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1. Receives: Drug: Chlorhexidine 0.2% mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 with 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 score is calculated at each time point (T0, T1, T2, T3, T4). Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe gingival inflammation or periodontal attachment loss.
The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two groups: MicroRepair® ABX mouthwash regimen vs chlorhexidine digluconate 0.2% mouthwash regimen. All participants receive supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol.
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. Possible scores range from 0% (no plaque) to 100% (plaque on all surfaces). Lower scores indicate better oral hygiene. For each participant, a mean FMPS is calculated at each time point (T0, T1, T2, T3, T4).
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)
The Full-Mouth Bleeding Score (FMBS) measures the percentage of bleeding sites after gentle probing at four sites per tooth (mesial, buccal, distal, lingual). FMBS 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. For each participant, a mean FMBS is calculated at each time point (T0, T1, T2, T3, T4).
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
Salivary activated Matrix Metalloproteinase-8 (aMMP-8) is a biomarker of periodontal inflammation and collagen breakdown. At baseline (T0) and 2 weeks (T1), unstimulated whole saliva samples are collected using a standardized sterile protocol. Participants refrain from eating, drinking, or brushing their teeth for at least 1 hour before collection. Saliva is collected passively into sterile tubes over 5 minutes, immediately frozen at -20°C, and later analyzed via immunoassay (enzyme-linked immunosorbent assay, ELISA).
Results are expressed in nanograms per milliliter (ng/mL) and interpreted as: <8 ng/mL = no inflammation; 9-19 ng/mL = mild inflammation; >20 ng/mL = severe inflammation. For each participant, mean aMMP-8 levels will be calculated at T0 and T1.
Measured: Baseline (T0), 2 weeks (T1)
Change in gingival recession assessed by Recession (REC)
Gingival Recession (REC) is defined as the distance in millimeters from the cemento-enamel junction (CEJ) to the gingival margin, measured at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a calibrated periodontal probe (Hu-Friedy PCP UNC 15). Measurements are performed at baseline (T0), after completion of the 14-day mouthwash protocol (T1, 2 weeks), following professional supragingival prophylaxis (T2, 1 month), and during the subsequent follow-up visits (T3, 3 months, and T4, 6 months). Scores range from 0 mm (no recession) to values exceeding 5 mm in cases of severe gingival recession. For each patient, a mean REC score is calculated at every time point (T0-T4) to monitor potential soft tissue loss over the study period. Mean REC values will be compared between the MicroRepair® ABX mouthwash regimen and the chlorhexidine digluconate 0.2% 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 defined as the distance in millimeters from the cemento-enamel junction (CEJ) to the base of the periodontal pocket, recorded at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a calibrated periodontal probe (Hu-Friedy PCP UNC 15). Measurements are performed at baseline (T0), after completion of the 14-day mouthwash regimen (T1, 2 weeks), following professional supragingival prophylaxis (T2, 1 month), and at subsequent follow-up visits (T3, 3 months, and T4, 6 months). CAL values typically range from 0 mm (healthy periodontium) to ≥7 mm (advanced attachment loss). For each patient, a mean CAL score is calculated at every time point (T0-T4). Mean CAL values will be compared between the MicroRepair® ABX mouthwash regimen and the chlorhexidine digluconate 0.2% mouthwash regimen to assess differences in periodontal tissue attachment loss.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in extrinsic staining assessed by Lobene Stain Index Modified
The Modified Lobene Stain Index is used to evaluate extrinsic dental staining on vestibular and lingual/palatal tooth surfaces by assessing both stain intensity and extent. Intensity is scored as 0 = no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain. Extent is scored as 0 = no stain, 1 = stain covering up to one-third of the surface, 2 = stain covering between one-third and two-thirds of the surface, and 3 = stain covering more than two-thirds of the surface. The final score for each surface is obtained by multiplying intensity by extent, with higher scores indicating more pronounced staining. Assessments are conducted at baseline (T0), after completion of the 14-day mouthwash regimen (T1, 2 weeks), following professional supragingival prophylaxis (T2, 1 month), and during subsequent follow-up visits (T3, 3 months, and T4, 6 months). The index is used to compare the staining potential of the MicroRepair® ABX mouthwash regimen versus the chlorhexidine digluconate 0.2%
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in dentin hypersensitivity assessed by Schiff Air Index
The Schiff Air Index is employed to assess dentin hypersensitivity in response to a standardized air stimulus directed onto the vestibular surface of each tooth. Responses are scored as 0 = no response, 1 = response without request to discontinue the stimulus, 2 = response with a request to discontinue the stimulus, and 3 = painful response with immediate withdrawal or visible discomfort. For each patient, a mean Schiff score is calculated at every evaluation. Measurements are performed at baseline (T0), after completion of the 14-day mouthwash regimen (T1, 2 weeks), following professional supragingival prophylaxis (T2, 1 month), and during the follow-up visits (T3, 3 months, and T4, 6 months). Scores will be compared between the MicroRepair® ABX mouthwash regimen and the chlorhexidine digluconate 0.2% regimen to determine the impact of treatments on dentin hypersensitivity over time.
Measured: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
Change in taste perception assessed by a validated taste alteration questionnaire
Taste perception will be assessed using a validated patient-reported questionnaire designed to capture the presence and severity of taste alterations, including bitter, metallic, or unpleasant sensations. Each item is scored on a 5-point Likert scale, where 0 = no alteration, 1 = mild alteration, 2 = moderate alteration, 3 = severe alteration, and 4 = very severe alteration. For each patient, a total score is calculated, with higher values indicating more pronounced dysgeusia. Evaluations are performed at baseline (T0), after completion of the 14-day mouthwash regimen (T1, 2 weeks), following the first professional supragingival prophylaxis (T2, 1 month), and during follow-up visits (T3, 3 months, and T4, 6 months). Mean scores will be compared between the MicroRepair® ABX mouthwash regimen and the chlorhexidine 0.2% regimen to assess and compare the tolerability of the interventions over time.
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 Gingivitis and 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
- 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
- NCT07088666
- Sponsor's protocol ID
- 2025-CHX0.2vsMICRO
- Acronym
- GEM-CHX02
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2025
- Last updated
- 29 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 0.2% Chlorhexidine and MicroRepair ABX Mouthwash in Patients With Plaque-Induced Gingivitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07088666
- Acronym / sponsor ID
- GEM-CHX02 / 2025-CHX0.2vsMICRO
- Keywords
- Chlorhexidine 0.2%, MicroRepair ABX, Gingivitis, Plaque-induced gingivitis, Mouthwash, Oral hygiene, Dental plaque, aMMP-8
- 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.
Gingivitis is the most common form of reversible gum disease, caused by the accumulation of dental plaque. It leads to inflammation of the gums, bleeding, and discomfort, but it can be managed and reversed with professional dental cleaning and proper oral hygiene.
Chlorhexidine 0.2% mouthwash is considered the "gold standard" in reducing plaque and gingival inflammation. However, its long-term use may cause side effects such as tooth staining, changes in taste, and irritation of the oral tissues. MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals with antibacterial components, has shown promising properties in reducing plaque and supporting gum health, with potentially fewer side effects.
This randomized controlled clinical trial will compare the effectiveness of 0.2% chlorhexidine mouthwash and MicroRepair® ABX mouthwash, both used after professional dental cleaning, in patients with plaque-induced gingivitis. Forty participants will be randomly assigned to one of the two treatments for 14 days.
The primary outcome will be the change in gum pocket depth, measured as Probing Pocket Depth (PPD). Secondary outcomes include changes in plaque accumulation, measured as Full-Mouth Plaque Score (FMPS); gum bleeding, measured as Full-Mouth Bleeding Score (FMBS); attachment of the gums to the teeth, measured as Clinical Attachment Level (CAL); gum recession, measured as Recession (REC); tooth staining, measured with the Lobene Stain Index; tooth sensitivity, measured with the Schiff Air Index; taste alterations assessed through a validated questionnaire; and salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a biomarker of gum inflammation.
The goal of this study is to determine whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in treating plaque-induced gingivitis, while offering better tolerability and fewer side effects.
Detailed description
Gingivitis is a reversible inflammatory condition of the gums, caused by the accumulation of dental plaque. It is characterized by gum redness, swelling, and bleeding, but it does not involve loss of attachment or bone support. Although it can be effectively managed, untreated gingivitis may progress to periodontitis, which is a more severe and irreversible disease.
Chlorhexidine digluconate 0.2% is widely regarded as the gold standard among antiseptic mouthwashes because of its proven antibacterial and anti-plaque properties. Nevertheless, its long-term use is limited by adverse effects, including tooth and tongue staining, altered taste perception, and mucosal irritation. For this reason, alternative formulations with similar antibacterial potential but fewer side effects are under investigation.
MicroRepair® ABX mouthwash contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. Zinc-hydroxyapatite has shown the ability to reduce plaque accumulation, promote enamel remineralization, and support gum health without cytotoxic effects. Despite encouraging in vitro results and clinical studies in other conditions, there is still a lack of randomized controlled trials directly comparing MicroRepair® ABX with chlorhexidine 0.2% in patients with plaque-induced gingivitis.
This study aims to fill this gap by evaluating whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in reducing gingival inflammation after professional dental cleaning. In addition to standard clinical measures-such as Probing Pocket Depth (PPD), Full-Mouth Plaque Score (FMPS), Full-Mouth Bleeding Score (FMBS), Clinical Attachment Level (CAL), and Recession (REC)-the trial will also assess patient-related outcomes including tooth staining (Lobene Stain Index), dentinal sensitivity (Schiff Air Index), and taste alterations. Furthermore, salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a sensitive biomarker of periodontal inflammation, will be analyzed to provide insight into the biological mechanisms of action.
By integrating both clinical and biomolecular outcomes, this study will generate robust evidence on whether MicroRepair® ABX can serve as a safe and effective alternative to chlorhexidine 0.2% 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 | Experimental | Drug: MicroRepair ABX mouthwashParticipants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour. Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1. |
| 0.2% Chlorhexidine Mouthwash | Active comparator | Drug: Chlorhexidine 0.2% mouthwashParticipants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use chlorhexidine digluconate 0.2% mouthwash, considered the gold standard for chemical plaque control. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour. Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1. |
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 (FMBS ≥ 25%, PPD ≤ 3 mm in ≥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 CAL ≥1 mm at ≥2 non-adjacent teeth)
- Systemic diseases affecting periodontal status (e.g., diabetes, immunodeficiencies)
- Antibiotic or anti-inflammatory therapy in the last 3 months
- Professional dental cleaning in the past 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: Hydroxyapatite-based mouthwashAt baseline (T0), participants receive clinical assessments, oral hygiene instruction, and begin a 14-day home regimen with MicroRepair® ABX mouthwash, which contains zinc-hydroxyapatite microcrystals and antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). The mouthwash is used twice daily (10 mL for 30 seconds) after toothbrushing, without rinsing, and participants avoid food or drink for 1 hour. All participants use a sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study. At 1 month (T1), participants undergo professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, ultrasonic debridement with an EMS Piezon piezoelectric device, and air-polishing with glycine powder. At 3 months (T2) and 6 months (T3), additional GBT sessions and a repeated 14-day mouthwash cycle are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%. | Drug | MicroRepair ABX Mouthwash |
| Chlorhexidine 0.2% mouthwashAlso: Chlorhexidine digluconate 0.2%At baseline (T0), participants undergo clinical and photographic assessments, receive oral hygiene instruction, and begin a 14-day home regimen with 0.2% chlorhexidine digluconate mouthwash, used twice daily (10 mL for 30 seconds) after toothbrushing. The solution is not rinsed away, and participants avoid food or drink for 1 hour. All participants use a standardized sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®). At 1 month (T1), participants receive professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, piezoelectric ultrasonic scaling with an EMS Piezon device, and air-polishing with glycine powder. At 3 months (T2) and 6 months (T3), additional GBT sessions and repetition of the 14-day home regimen are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%. | Drug | 0.2% Chlorhexidine Mouthwash |
Primary outcome
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)
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 with 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 score is calculated at each time point (T0, T1, T2, T3, T4). Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe gingival inflammation or periodontal attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two groups: MicroRepair® ABX mouthwash regimen vs chlorhexidine digluconate 0.2% mouthwash regimen. All participants receive supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol.
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 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)
Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels
Time frame: Baseline (T0), 2 weeks (T1)
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 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 extrinsic staining assessed by Lobene Stain Index Modified
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
Time frame: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)
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 29 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 0.2% mouthwash in people with Gingivitis and Periodontal Diseases 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 29 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 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)). 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 29 Apr 2026.