Peri-implant MucositisNCT04899986
Chlorhexidine Gel and Peribioma Periogel Use in Peri-implant Mucositis Sites: a Split-mouth Randomized Clinical Trial.
A study testing Chlorhexidine and Biorepair gel and toothpaste application and Standard oral hygiene in people with Peri-implant Mucositis, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis. Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Chlorhexidine and Biorepair gel and toothpaste application and Standard oral hygiene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 16 Jan 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
- Adult patients (18-70 years)
- Bilateral presence of peri-implant mucositis
- Patients with high compliance
Who cannot join
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Patients suffering from systemic, metabolic or autoimmune diseases
- Pregnant women
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: Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.
Read the detailed description
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups:
- Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.
- Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.
- Conditions
- Peri-implant Mucositis
- Being tested
- Chlorhexidine and Biorepair gel and toothpaste application, Standard oral hygiene
- Keywords
- non-surgical periodontal therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine and Biorepair gel and toothpaste applicationOther
Split-mouth application of chlorhexidine gel 1% (quadrants 1 and 4) and Biorepair Periogel (quadrants 2 and 3) after professional dental hygiene. Home oral care will be continued with chlorhexidine 0,12% gel and Biorepair Periogel in the same quadrants, for the following 15 days from the visits, together with the use of Biorepair Parodontogel toothpaste.
Standard oral hygieneOther
Use of standard toothpastes for home oral hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Trial Group | Experimental | Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care. Receives: Other: Chlorhexidine and Biorepair gel and toothpaste application |
| Control Group | Active comparator | Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes. Receives: Other: Standard oral hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOP - Bleeding On Probing
Dichotomous scoring (yes/no)
Measured: Baseline, 1, 3 and 6 months.
Change in GBI - Gingival Bleeding Index (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.
The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Measured: Baseline, 1, 3 and 6 months.
Change in suppuration
Dichotomous scoring (yes/no)
Measured: Baseline, 1, 3 and 6 months.
Change in marginal mucosa condition
Scoring criteria:
- 0: normal mucosa
- 1: minimal inflammation with color change and minor edema
- 2: moderate inflammation with redness, edema and glazing
- 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Measured: Baseline, 1, 3 and 6 months.
Change in mucosal margin
Dichotomous scoring (migrated/non migrated)
Measured: Baseline, 1, 3 and 6 months.
Probing Pocket Depth
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, 1, 3 and 6 months.
Change in PI - Plaque Index (percentage)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Measured: Baseline, 1, 3 and 6 months.
Change in BS - Bleeding Score
Scoring criteria:
- 0: no bleeding
- 1: isolated visible spots
- 2: blood forms a confluent red line on mucosal margin
- 3: heavy or profuse bleeding
Measured: Baseline, 1, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start15 May 2021
- Primary completion14 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899986
- Sponsor's protocol ID
- 2021-PBIMPLANT
- Status last verified
- Jan 2022
- First submitted
- 19 May 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04899986
- Acronym / sponsor ID
- 2021-PBIMPLANT
- Conditions
- Peri-implant Mucositis
- Keywords
- non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 25 May 2021 (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.
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.
Detailed description
The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.
Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups:
- Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.
- Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.
The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial Group | Experimental | Other: Chlorhexidine and Biorepair gel and toothpaste applicationPatients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care. |
| Control Group | Active comparator | Other: Standard oral hygienePatients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18-70 years)
- Bilateral presence of peri-implant mucositis
- Patients with high compliance
Key exclusion criteria (4 listed)
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Patients suffering from systemic, metabolic or autoimmune diseases
- Pregnant women
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 |
|---|---|---|
| Chlorhexidine and Biorepair gel and toothpaste applicationSplit-mouth application of chlorhexidine gel 1% (quadrants 1 and 4) and Biorepair Periogel (quadrants 2 and 3) after professional dental hygiene. Home oral care will be continued with chlorhexidine 0,12% gel and Biorepair Periogel in the same quadrants, for the following 15 days from the visits, together with the use of Biorepair Parodontogel toothpaste. | Other | Trial Group |
| Standard oral hygieneUse of standard toothpastes for home oral hygiene. | Other | Control Group |
Primary outcome
Change in BOP - Bleeding On Probing
Time frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in GBI - Gingival Bleeding Index (percentage)
Time frame: Baseline, 1, 3 and 6 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Change in suppuration
Time frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in marginal mucosa condition
Time frame: Baseline, 1, 3 and 6 months.
Scoring criteria: * 0: normal mucosa * 1: minimal inflammation with color change and minor edema * 2: moderate inflammation with redness, edema and glazing * 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Change in mucosal margin
Time frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (migrated/non migrated)
Probing Pocket Depth
Time frame: Baseline, 1, 3 and 6 months.
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.
Change in PI - Plaque Index (percentage)
Time frame: Baseline, 1, 3 and 6 months.
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Change in BS - Bleeding Score
Time frame: Baseline, 1, 3 and 6 months.
Scoring criteria: * 0: no bleeding * 1: isolated visible spots * 2: blood forms a confluent red line on mucosal margin * 3: heavy or profuse bleeding
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 31 Jan 2022.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to Principal Investigator
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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, DDS, PhD. 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 Chlorhexidine and Biorepair gel and toothpaste application and Standard oral hygiene in people with Peri-implant Mucositis, 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 4 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 31 Jan 2022. 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 BOP - Bleeding On Probing (time frame: Baseline, 1, 3 and 6 months.). The study lists 8 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 31 Jan 2022.