Periodontal DiseasesNCT04781478
Treatment of Periodontal Disease With Two Different Bioactive Gels for Home Oral Care
A study testing Application of Biorepair Gel and Irrigation of Chlorhexidine 1.00% gel in people with Periodontal Diseases, run by University of Pavia at 1 site in Italy.
Trial summary
This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Application of Biorepair Gel and Irrigation of Chlorhexidine 1.00% gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Mar 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):
- 1.1 Severity from grade I onwards (grade I: clinical attachment loss of 1-2 mm, bone loss in the cervical third greater than 15%, no elements loss for periodontitis);
- 1.2. Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
- Presence of bilateral periodontal probes, both to the right and to the left of the midline incisal line.
- Subjects who gave their written informed consent to take part of the study.
Who cannot join
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Pregnant or breastfeeding women
- Cancer patients undergoing therapy
- Patients taking bisphosphonates within the last 12 months
- Patients with low compliance or inconsistent motivation
- Drug or alcohol users
- Presence of periodontal probes exclusively on the right or left side compared to the midline incisal line
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: Home Oral Care With Biorepair Implant Bioactive Gel and Chlorhexidine Gel 1% for the Improvement of Inflammatory Epidemiological Indices in Periodontal Patients: a Split-mouth Randomised Clinical Trial
This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel 1%. Patients will continue to use gels at home for the following 14 days and on the same quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from the baseline.
Patients are divided into two groups with inverted quadrants administration in order to evaluate the improvements of periodontal inflammation indices and to assess the efficacy of Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.
Read the detailed description
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health.
Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups:
- Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel.
- Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel.
Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session.
The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).
- Conditions
- Periodontal Diseases
- Being tested
- Application of Biorepair Gel, Irrigation of Chlorhexidine 1.00% gel
- Keywords
- split-mouth, periodontal gel, scaling and root planning, periodontal disease, dental hygiene
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Biorepair GelOther
Professional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders).
Irrigation of Chlorhexidine 1.00% gelOther
Irrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders).
| Study group | Role | What they receive |
|---|---|---|
| Biorepair Gel (Q1-Q3) and Chlorhexidine 1% gel (Q2-Q4) | Active comparator | The patients receive Biorepair Gel application in quadrants Q1 and Q3, whereas they receive chlorhexidine 1% gel in quadrants Q2 and Q4. Receives: Other: Application of Biorepair Gel; Other: Irrigation of Chlorhexidine 1.00% gel |
| Chlorhexidine 1% gel (Q1-Q3) and Biorepair Gel (Q2-Q4) | Active comparator | The patients receive chlorhexidine 1% gel in quadrants Q1 and Q3, whereas they receive Biorepair Gel application in quadrants Q2 and Q4. Receives: Other: Application of Biorepair Gel; Other: Irrigation of Chlorhexidine 1.00% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOP% - Bleeding on Probing %
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: 1, 3 and 6 months.
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: 1, 3 and 6 months.
R - Gingival recession
Evaluation (in mm) of the distance between the gingival margin and the amelo-cemental junction (JEC). It is the exposure of the root surface, following the apical migration of periodontal structure.
Measured: 1, 3 and 6 months.
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: 1, 3 and 6 months.
Dental mobility (Miller, 1985)
It is classified using numerical values:
- Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems;
- Grade I: horizontal mobility of the tooth from 0.2 to 1 mm;
- Grade II: horizontal mobility of the tooth from 1 to 2 mm;
- Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
Measured: 1, 3 and 6 months.
Secondary outcomes (1)
Comparison between biorepair gel and chlorhexidine 1% gel
Comparing the measurements of periodontal indices in the two groups for the two different periodontal gels administered.
Measured: 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 posted4 Mar 2021
- Study start16 Mar 2021
- Primary completion10 Oct 2021
- Study completion15 Oct 2021
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
- Model description
- Patients are divided in two groups. Both groups are treated with non-surgical periodontal therapy (baseline and 1, 3, 6 months after the first professional oral hygiene). Patients in the first group receive Biorepair gel in quadrants Q1 and Q4 and chlorhexidine 1% gel in quadrants Q2 and Q3; for patients in the second group the situation is inverted. In this way, it is possible to compare the general periodontal condition and the quadrants treated with the two different gels.
- 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., Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781478
- Sponsor's protocol ID
- 2021-BIOCHD
- Status last verified
- Oct 2021
- First submitted
- 22 Feb 2021
- Last updated
- 8 Nov 2021
- 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 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Oral Care With Biorepair Implant Bioactive Gel and Chlorhexidine Gel 1% for the Improvement of Inflammatory Epidemiological Indices in Periodontal Patients: a Split-mouth Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04781478
- Acronym / sponsor ID
- 2021-BIOCHD
- Conditions
- Periodontal Diseases
- Keywords
- split-mouth, periodontal gel, scaling and root planning, periodontal disease, dental hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 4 Mar 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.
This study is an open-label split-mouth study in which periodontal patients will be treated in order to obtain periodontal health. After non-surgical therapy and air-perio polishing, a periodontal in-situ gelling product (Biorepair Implant Bioactive gel) will be applied in periodontal pockets in two quadrants (Q1-Q3 or Q2-Q4) of the mouth of the participants. At the same time, pockets of the contralateral quadrant will be irrigated with chlorhexidine gel 1%. Patients will continue to use gels at home for the following 14 days and on the same quadrants. Professional ora hygiene session will be performed after 1, 3 and 6 months from the baseline.
Patients are divided into two groups with inverted quadrants administration in order to evaluate the improvements of periodontal inflammation indices and to assess the efficacy of Biorepair Implant Bioactive gel compared to chlorhexidine 1% gel treatment.
Detailed description
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health.
Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups:
- Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel.
- Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel.
Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session.
The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are divided in two groups. Both groups are treated with non-surgical periodontal therapy (baseline and 1, 3, 6 months after the first professional oral hygiene). Patients in the first group receive Biorepair gel in quadrants Q1 and Q4 and chlorhexidine 1% gel in quadrants Q2 and Q3; for patients in the second group the situation is inverted. In this way, it is possible to compare the general periodontal condition and the quadrants treated with the two different gels.
| Arm | Type | Receives |
|---|---|---|
| Biorepair Gel (Q1-Q3) and Chlorhexidine 1% gel (Q2-Q4) | Active comparator | Other: Application of Biorepair Gel, Other: Irrigation of Chlorhexidine 1.00% gelThe patients receive Biorepair Gel application in quadrants Q1 and Q3, whereas they receive chlorhexidine 1% gel in quadrants Q2 and Q4. |
| Chlorhexidine 1% gel (Q1-Q3) and Biorepair Gel (Q2-Q4) | Active comparator | Other: Application of Biorepair Gel, Other: Irrigation of Chlorhexidine 1.00% gelThe patients receive chlorhexidine 1% gel in quadrants Q1 and Q3, whereas they receive Biorepair Gel application in quadrants Q2 and Q4. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of periodontal disease according to the recent 2017 classification (2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions):
- 1.1 Severity from grade I onwards (grade I: clinical attachment loss of 1-2 mm, bone loss in the cervical third greater than 15%, no elements loss for periodontitis);
- 1.2. Complexity from grade II onwards (grade II: maximum probing depth of 5 mm, bone loss mainly horizontally);
- Presence of bilateral periodontal probes, both to the right and to the left of the midline incisal line.
- Subjects who gave their written informed consent to take part of the study.
Key exclusion criteria (8 listed)
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Pregnant or breastfeeding women
- Cancer patients undergoing therapy
- Patients taking bisphosphonates within the last 12 months
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 |
|---|---|---|
| Application of Biorepair GelProfessional application of Biorepair Gel after Scaling and Root Planing and Air-Perio polishing (glycine powders). | Other | Biorepair Gel (Q1-Q3) and Chlorhexidine 1% gel (Q2-Q4), Chlorhexidine 1% gel (Q1-Q3) and Biorepair Gel (Q2-Q4) |
| Irrigation of Chlorhexidine 1.00% gelIrrigation of periodontal pockets with Chlorhexidine 1.00% gel afterScaling and Root Planing and Air-Perio polishing (glycine powders). | Other | Biorepair Gel (Q1-Q3) and Chlorhexidine 1% gel (Q2-Q4), Chlorhexidine 1% gel (Q1-Q3) and Biorepair Gel (Q2-Q4) |
Primary outcome
BOP% - Bleeding on Probing %
Time frame: 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%.
PPD - Probing Pocket Depth
Time frame: 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.
R - Gingival recession
Time frame: 1, 3 and 6 months.
Evaluation (in mm) of the distance between the gingival margin and the amelo-cemental junction (JEC). It is the exposure of the root surface, following the apical migration of periodontal structure.
PCR% - Plaque Control Record
Time frame: 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.
Dental mobility (Miller, 1985)
Time frame: 1, 3 and 6 months.
It is classified using numerical values: 0. Grade 0: oscillation within 0.2 mm; the teeth move naturally and there are no mobility problems; 1. Grade I: horizontal mobility of the tooth from 0.2 to 1 mm; 2. Grade II: horizontal mobility of the tooth from 1 to 2 mm; 3. Grado III: horizontal mobility equal to or greater than 3 mm or vertical mobility of the tooth.
1 secondary outcome
Comparison between biorepair gel and chlorhexidine 1% gel
Time frame: 1, 3 and 6 months.
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 8 Nov 2021.
- 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 Application of Biorepair Gel and Irrigation of Chlorhexidine 1.00% gel 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 5 inclusion and 8 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 8 Nov 2021. 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?
BOP% - Bleeding on Probing % (time frame: 1, 3 and 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.