PeriodontitisNCT04662216
Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment
A study testing Scaling and root planing and Scaling and root planing + "Perisolv" +"Hyadent BG" gels in people with Periodontitis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing and Scaling and root planing + "Perisolv" +"Hyadent BG" gels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 4 Oct 2019to 1 May 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 30 years old;
- Good general health according to medical history and clinical judgment;
- Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm;
- Radiographic evidence of bone loss ( > 2 mm from cemento-enamel junction (CEJ) );
- Untreated periodontal disease;
- Minimum 20 teeth (wisdom teeth excluded);
- No removable prosthesis.
Who cannot join
- Patients already included in other clinical trials;
- Periodontal treatment during the last 12 months;
- Antibiotic treatment 6 months prior to the start of the trial;
- Antibiotic prophylaxis required for dental treatment;
- Ongoing medication that may affect the clinical features of periodontitis;
- Pregnant/lactating.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Lithuanian University of Health Sciences
Kaunas, Kauno, 44307
About this study
Official title: Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial
The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.
Read the detailed description
Objectives:
- To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients.
- To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone.
The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv"+ Hyadent BG gels.
The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste.
Teeth in the test group (all teeth with PD ≥ 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel.
Teeth in control group will receive SRP + polishing
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing, Scaling and root planing + "Perisolv" +"Hyadent BG" gels
- Keywords
- periodontitis, scaling and root planing, sodium hypochlorite
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).
Scaling and root planing + "Perisolv" +"Hyadent BG" gelsProcedure or surgery
Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes), "Perisolv" gel will adjectively be applied to all pockets with probing depth(PD) ≥ 5 mm, which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Afterwards, all teeth will be polished and all treated pockets will be filled with hyaluronic acid gel (Hyadent BG).
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Scaling and root planing Receives: Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gels |
| test group | Experimental | scaling and root planing + "Perisolv" +"Hyadent BG" gels. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth (PD) reduction
PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket
Measured: 6 months
Secondary outcomes (4)
Clinical attachment level (CAL)
CAL (clinical attachment level): will be calculated for each site as the sum of PD and the gingival recession/overgrowth.
Measured: 6 months
Bleeding on probing (BOP)
BOP (bleeding on probing): presence (+) or absence (-) of bleeding within 15s after probing the pocket (%).
Measured: 6 months
Plaque Index (PI)
PI (Plaque index): presence of dental plaque along the mucosal margin at 6 sites of the implant presence (+) or absence (-).
Measured: 6 months
Reduction of total counts of periodontopathogenic bacteria
Subgingival plaque samples will be analyzed for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia Treponema denticola and Prevotella intermedia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start4 Oct 2019
- Primary completion1 Oct 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv" +"Hyadent BG" gels.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Egle Ramanauskaite, Lithuanian University of Health Sciences
- Investigators
- Vita Machiulskiene, Prof, Study chair, LUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662216
- Sponsor's protocol ID
- Protocol1, Version2
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
PubMed 37740107
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04662216
- Acronym / sponsor ID
- Protocol1, Version2
- Conditions
- Periodontitis
- Keywords
- periodontitis, scaling and root planing, sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Dec 2020 (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 study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.
Detailed description
Objectives:
- To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients.
- To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone.
The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv"+ Hyadent BG gels.
The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste.
Teeth in the test group (all teeth with PD ≥ 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel.
Teeth in control group will receive SRP + polishing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv" +"Hyadent BG" gels.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: Scaling and root planing + "Perisolv" +"Hyadent BG" gelsScaling and root planing |
| test group | Experimental | Procedure: Scaling and root planingscaling and root planing + "Perisolv" +"Hyadent BG" gels. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 30 years old;
- Good general health according to medical history and clinical judgment;
- Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm;
- Radiographic evidence of bone loss ( > 2 mm from cemento-enamel junction (CEJ) );
- Untreated periodontal disease;
Key exclusion criteria (6 listed)
- Patients already included in other clinical trials;
- Periodontal treatment during the last 12 months;
- Antibiotic treatment 6 months prior to the start of the trial;
- Antibiotic prophylaxis required for dental treatment;
- Ongoing medication that may affect the clinical features of periodontitis;
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 |
|---|---|---|
| Scaling and root planingScaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes). | Procedure or surgery | test group |
| Scaling and root planing + "Perisolv" +"Hyadent BG" gelsScaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes), "Perisolv" gel will adjectively be applied to all pockets with probing depth(PD) ≥ 5 mm, which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Afterwards, all teeth will be polished and all treated pockets will be filled with hyaluronic acid gel (Hyadent BG). | Procedure or surgery | control group |
Primary outcome
Probing depth (PD) reduction
Time frame: 6 months
PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket
4 secondary outcomes
Clinical attachment level (CAL)
Time frame: 6 months
Bleeding on probing (BOP)
Time frame: 6 months
Plaque Index (PI)
Time frame: 6 months
Reduction of total counts of periodontopathogenic bacteria
Time frame: 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 26 Aug 2022.
- Derived from this study: PubMed 37740107Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
- Individual participant dataSharing planned: No
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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.
Vita Machiulskiene, Prof study chair
LUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing and Scaling and root planing + "Perisolv" +"Hyadent BG" gels in people with Periodontitis, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 7 inclusion and 6 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 26 Aug 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 Lithuania. 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?
Probing depth (PD) reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662216, which also lists 1 linked publication.
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 26 Aug 2022.