Periodontal DiseasesNCT05400538
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral Health
A study testing Biorepair Toothpaste + Mousse and Biorepair Toothpaste in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women. Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Biorepair Toothpaste + Mousse and Biorepair Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2022to 20 Oct 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women at the 4th month of pregnancy
Who cannot join
- presence of cardiac pacemaker
- neurological and psychiatric diseases
- patients taking bisphosphonates during the previous 12 months from the beginning of the study
- patients undergoing anticancer therapy.
- patients with poor compliance.
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: Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
Read the detailed description
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.
- Conditions
- Periodontal Diseases
- Being tested
- Biorepair Toothpaste + Mousse, Biorepair Toothpaste
- Keywords
- pregnancy
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Toothpaste + MousseOther
Domiciliary application of the products twice a day.
Biorepair ToothpasteOther
Domiciliary application of the product twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Biorepair Toothpaste + Mousse domiciliary use Receives: Other: Biorepair Toothpaste + Mousse |
| Control group | Active comparator | Biorepair Toothpaste domiciliary use. Receives: Other: Biorepair Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PPD - 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, after 1, 3 and 6 months.
Change in BOP - Bleeding on Probing (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.
Percentage of sites with bleeding on probing determines the BOP%.
Measured: Baseline, after 1, 3 and 6 months.
Change in CAL - Clinical Attachment Loss
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Measured: Baseline, after 1, 3 and 6 months.
Change in R - Gingival recession
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Measured: Baseline, after 1, 3 and 6 months.
Change in PCR% - Plaque Control Record
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Measured: Baseline, after 1, 3 and 6 months.
Change in MGI - Modified Gingival Index
Scoring criteria:
- 0: normal
- 1: mild inflammation (slight changes in color and texture, but not in all portions of gingival marginal or papillary)
- 2: mild inflammation (slight changes in color and texture in all portions of gingival marginal or papillary)
- 3: moderate (bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary)
- 4: severe inflammation (erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration)
Measured: Baseline, after 1, 3 and 6 months.
Change in PMGI - Papillary Marginal Gingival Index
Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
Measured: Baseline, after 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 posted1 Jun 2022
- Study start10 Jun 2022
- Primary completion10 Oct 2023
- Study completion20 Oct 2023
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05400538
- Sponsor's protocol ID
- 2022-PREGNANCY
- Status last verified
- Dec 2023
- First submitted
- 27 May 2022
- Last updated
- 5 Dec 2023
- 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 Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Domiciliary Oral Hygiene.
- ClinicalTrials.gov ID
- NCT05400538
- Acronym / sponsor ID
- 2022-PREGNANCY
- Conditions
- Periodontal Diseases
- Keywords
- pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 1 Jun 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.
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months.
Detailed description
The aim of the present study is to evaluate the use of probiotics in domiciliary oral hygiene procedures in pregnant women.
Patients consenting to participate to the study will undergo periodontal evaluation at the baseline (T0). Then, professional dental hygiene will be performed. Patients will be randomly assigned to:
- Trial group: home oral application of Biorepair Peribioma Toothpaste + Biorepair Peribioma mousse twice a day
- Control group: home oral application of Biorepair Peribioma Toothpaste
Patients will be evaluated after 1 month (T1), 3 (T2) and 6 (T3) months, the following indexes will be assessed: Probing Pocket Depth, Bleeding on Probing (percentage), Clinical Attachment Loss, Gingival recession, Plaque Control Record, Modified Gingival Index, Papillary Marginal Gingival Index.
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: Biorepair Toothpaste + MousseBiorepair Toothpaste + Mousse domiciliary use |
| Control group | Active comparator | Other: Biorepair ToothpasteBiorepair Toothpaste domiciliary use. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women at the 4th month of pregnancy
Key exclusion criteria (5 listed)
- presence of cardiac pacemaker
- neurological and psychiatric diseases
- patients taking bisphosphonates during the previous 12 months from the beginning of the study
- patients undergoing anticancer therapy.
- patients with poor compliance.
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 |
|---|---|---|
| Biorepair Toothpaste + MousseDomiciliary application of the products twice a day. | Other | Trial group |
| Biorepair ToothpasteDomiciliary application of the product twice a day. | Other | Control group |
Primary outcome
Change in PPD - Probing Pocket Depth
Time frame: Baseline, after 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 BOP - Bleeding on Probing (percentage)
Time frame: Baseline, after 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. Percentage of sites with bleeding on probing determines the BOP%.
Change in CAL - Clinical Attachment Loss
Time frame: Baseline, after 1, 3 and 6 months.
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Change in R - Gingival recession
Time frame: Baseline, after 1, 3 and 6 months.
Distance (in mm) between the gingival margin and the amelo-cemental junction.
Change in PCR% - Plaque Control Record
Time frame: Baseline, after 1, 3 and 6 months.
% assessment of the amount of plaque on dental surfaces; it is detected on 4 surfaces: distal, mesial, vestibular, lingual / palatal. The number of sites with plaque is divided by the total number of sites available in the mouth and multiplied by 100. Results indicate the index as a percentage.
Change in MGI - Modified Gingival Index
Time frame: Baseline, after 1, 3 and 6 months.
Scoring criteria: * 0: normal * 1: mild inflammation (slight changes in color and texture, but not in all portions of gingival marginal or papillary) * 2: mild inflammation (slight changes in color and texture in all portions of gingival marginal or papillary) * 3: moderate (bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary) * 4: severe inflammation (erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration)
Change in PMGI - Papillary Marginal Gingival Index
Time frame: Baseline, after 1, 3 and 6 months.
Numerical score from 0 to 3 of gingival inflammation. Papille and gingival margins (vestibular and lingual) are given a score from 0 to 3. The score is given by the total amount of inflamed sites on the total of examined sites.
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 5 Dec 2023.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the 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, 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 Biorepair Toothpaste + Mousse and Biorepair Toothpaste 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 1 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 5 Dec 2023. 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 PPD - Probing Pocket Depth (time frame: Baseline, after 1, 3 and 6 months.). The study lists 7 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 5 Dec 2023.