PeriodontitisNCT06522438
Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment
A study testing Hyaluronic Acid (HA) and Octenidine gel and Non-surgical periodontal treatment (NSPT) in people with Periodontitis and Wound Heal, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Wound Heal, Periodontal Pocket
- What is being tested?
- Hyaluronic Acid (HA) and Octenidine gel and Non-surgical periodontal treatment (NSPT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 and above
- Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.
- Periodontitis stage III/IV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm
- Willing to sign informed consent and comply with study procedures
Who cannot join
- Know hypersensitivity and/or allergy to any of the product's component (as per user leaflet)
- Self-reported pregnancy or lactation
- Smoking (current or in past 5 years), including e-cigarettes/vaping
- Medical history including diabetes mellitus or other serious medical/ psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or/and systemic antibiotic therapy during the 3 months preceding the baseline evaluation
- In chronic treatment with anti-inflammatory (including corticosteroids), anticoagulants/antiplatelets (including aspirin), immunosuppressants or other medication that can severely impact wound healing
Show all 9Show fewer
- History of alcohol or drug abuse
- Subgingival professional mechanical plaque removal (excluding not-extensive subgingival debridement as judged by the examining clinician) and/or surgical periodontal treatment within the last 12 months
- Other severe acute or chronic medical or psychiatric condition or psychological disorder, including limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed, or any additional conditions which, in the judgement of the investigator, would make the subject inappropriate for entry into this trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Centre for Oral Clinical Research (COCR)
London, E1 2AD
Miljana Bacevic, DDS, PhD, +44(0)207 882 6348, BHNT.Clinicaloralresearchcentre@nhs.net
Jeniffer Perussolo, DDS, MS, PhD, 02078828641, j.perussolo@qmul.ac.uk
- Recruiting
The Royal London Dental Hospital, Barts Health NHS Trust
London, E1 2AD
Miljana Bacevic, DDS, PhD, +44(0)207 882 6348, BHNT.Clinicaloralresearchcentre@nhs.net
Jeniffer Perussolo, DDS, MS, PhD, 02078828641, j.perussolo@qmul.ac.uk
About this study
Official title: Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
This parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.
The study will consist of 7- 8 visits.
- Conditions
- Periodontitis, Wound Heal, Periodontal Pocket, Periodontal Inflammation, Periodontal Attachment Loss
- Being tested
- Hyaluronic Acid (HA) and Octenidine gel, Non-surgical periodontal treatment (NSPT)
- Keywords
- Hyaluronic Acid, Octenidine, Biomarkers, Non-surgical periodontal treatment
- Medical subject headings
- Periodontitis, Periodontal Pocket, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA) and Octenidine gelCombination product
A thermosensitive gel with Hyaluronic Acid (HA) and Octenidine (Pocket-X®, Geistlich, Wolhusen, Switzerland) will be applied in the periodontal pockets ≥5mm immediately after the subgingival PMPR, by means of a pre-filled syringe bearing a thin plastic tip and following manufacturer's instructions.
Non-surgical periodontal treatment (NSPT)Procedure or surgery
Full mouth supragingival professional mechanical plaque removal (PMPR) and subgingival PMPR at sites with PPD ≥4mm will be performed with the aid of manual and power-driven instruments under local anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel. Receives: Combination Product: Hyaluronic Acid (HA) and Octenidine gel; Procedure: Non-surgical periodontal treatment (NSPT) |
| Control Group | Active comparator | Non-surgical periodontal treatment (NSPT) alone. Receives: Procedure: Non-surgical periodontal treatment (NSPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the expression of GCF wound healing biomarkers
Changes in the expression of GCF wound healing biomarkers at 1, 7, 15, 30 days and 3 months following treatment will be assessed. A subset of analytes involved in the healing process and signalling pathways such as i) inflammation/immune response (e.g., IL-1 β, IL-1 α, IL-6, IL-8, IL-4, IL-10,IL-17, TNF- α, MMP-1, MMP-8, MMP-9, TIMP-1), ii) bone formation/resorption (e.g., TGF- β, osteocalcin, osteopontin, osteoprotegerin, BMP-2), iii) oxidative stress (e.g., Myeloperoxidase), and iv) angiogenesis (e.g., VEGF, angiopoietin-1) will be selected based on the pathways identified and optimized in the genomic and proteomic work from our group. Multiplex immunoassays will be designed specifically for quantitative analyses in the GCF for the 2 groups at the different time points.
Measured: Baseline, 1, 7, 15, 30 days and 3 months following treatment
Secondary outcomes (13)
Changes in the Blood flow
Changes in the blood flow at 1, 7, 15, and 30 days following treatment, evaluated with Laser Speckle Contrast Imaging (LSCI)
Measured: Baseline and at 1, 7, 15, and 30 days following treatment.
Changes in the bacterial load
Changes in the bacterial load associated with treated sites at 7, 15, 30 days, and 3 months following intervention. Subgingival plaque samples will be analysed using next generation marker DNA sequencing to characterise the subgingival microbiota to identify and determine the levels of key periodontal bacterial pathogens and microbial community-wide changes in sites treated at the different time points.
Measured: Baseline and at 7, 15, 30 days and 3 months following treatment.
Changes in the probing pocket depth (PPD)
PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Measured: Baseline and at 3 months after intervention
Changes in the gingival recession (REC)
REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual).
Measured: Baseline and at 3 months after intervention
Changes in the clinical attachment level (CAL)
CAL will be calculated considering the values for PPD and REC in mm
Measured: Baseline and at 3 months after intervention
Changes in the Full mouth plaque score (FMPS)
FMPS will be recorded as a percentage of total surfaces (6 sites per tooth), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).
Measured: Baseline and at 3 months after intervention
Changes in the Full mouth bleeding score (FMBS)
FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).
Measured: Baseline and at 3 months after intervention
Changes in the suppuration
Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent).
Measured: Baseline and at 3 months after intervention
Soft tissues contour changes
Soft tissues contour changes will be assessed at 1, 7, 15, 30 days, and 3 months following treatment. An intra-oral 3D scanner will be used to capture and monitor soft tissue contour changes during early phase of healing. The obtained images will be then superimposed (baseline and follow-ups) and calculation of linear and volumetric changes of the soft tissue (magnitude of the swelling, changes in shape and volume) will be performed.
Measured: Baseline, 1, 7, 15, 30 days, and 3 months following treatment
Changes in the periodontal inflamed surface area (PISA)
The periodontal inflamed surface area (PISA) is expressed in mm2 and will be calculated as the sum of the PPD of BOP-positive sites for the total dentition, which can be easily calculated using routine periodontal charting.
Measured: Baseline and at 3 months after intervention
Dentin hypersensitivity
A 100-mm horizontal visual analog scale (VAS) will be used to assess dentine hypersensitivity. The VAS is scored from 0= none to 100= worst dentin hypersensitivity possible and the subject will indicate the degree by marking vertically across the VAS scale.
Measured: Baseline, 1, 7, 15, 30 days, and 3 months after procedure
Patient perception about therapy
The extent of discomfort and/or pain experienced will be evaluated using a 100-mm visual analog scale (VAS). The anchors for each end of the scales will be designated as 0=none to 100= worst. The extent of oedema, hematoma, high fever, and interference in daily activities during the initial weeks will also be evaluated in the same way.
Measured: 1,7 and 15 days after procedure
Global changes in quality of life
Periodontal health and quality of life following periodontal therapy will be measured through specific questionnaire at 3 months after treatment. Questionnaire will include questions to evaluate patient's perception of treatment on their periodontal health and quality of life. Patients will answer by selecting one of the following options: worsened a lot, worsened a little, stayed the same, improved a little, improved a lot, or don't know.
Measured: 3 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start3 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeniffer Perussolo, DDS, MS, PhD, Principal investigator, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522438
- Sponsor's protocol ID
- 346806
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Healing Dynamics and Microbial Changes Following the Use of a Novel Thermosensitive Gel With Hyaluronic Acid and Octenidine as an Adjunct to Non-surgical Periodontal Treatment
- ClinicalTrials.gov ID
- NCT06522438
- Acronym / sponsor ID
- 346806
- Conditions
- Periodontitis, Wound Heal, Periodontal Pocket, Periodontal Inflammation, Periodontal Attachment Loss
- Keywords
- Hyaluronic Acid, Octenidine, Biomarkers, Non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (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 parallel-group, pilot study will test the hypothesis that the adjunctive use of a thermosensitive gel containing Hyaluronic Acid (HA) and Octenidine to non-surgical periodontal treatment (NSPT) will be able to modulate the early wound healing events. This will be assessed through the expression of specific gingival crevicular fluid markers, as well as by changes in gingival blood flow (assessed by laser speckle contrast imaging), bacterial load, soft tissues contour, clinical parameters and patient-reported outcomes.
The study will involve up to 26 patients and will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust. Patients will be randomised to receive either NSPT alone or NSPT+ HA and Octenidine gel, and will be followed up to 3 months after treatment.
The study will consist of 7- 8 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Combination Product: Hyaluronic Acid (HA) and Octenidine gel, Procedure: Non-surgical periodontal treatment (NSPT)Non-surgical periodontal treatment (NSPT) plus Hyaluronic Acid (HA) and Octenidine gel. |
| Control Group | Active comparator | Procedure: Non-surgical periodontal treatment (NSPT)Non-surgical periodontal treatment (NSPT) alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 and above
- Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment, or exhibiting a ≥ 50% reduction in plaque score from the initial screening visit.
- Periodontitis stage III/IV (grades A to C) with at least one site per quadrant with PPD ≥5mm, bleeding on probing and attachment loss ≥5mm
- Willing to sign informed consent and comply with study procedures
Key exclusion criteria (9 listed)
- Know hypersensitivity and/or allergy to any of the product's component (as per user leaflet)
- Self-reported pregnancy or lactation
- Smoking (current or in past 5 years), including e-cigarettes/vaping
- Medical history including diabetes mellitus or other serious medical/ psychiatric conditions or transmittable diseases that according to the investigator may increase the risk associated with study participation
- History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures or/and systemic antibiotic therapy during the 3 months preceding the baseline evaluation
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 |
|---|---|---|
| Hyaluronic Acid (HA) and Octenidine gelA thermosensitive gel with Hyaluronic Acid (HA) and Octenidine (Pocket-X®, Geistlich, Wolhusen, Switzerland) will be applied in the periodontal pockets ≥5mm immediately after the subgingival PMPR, by means of a pre-filled syringe bearing a thin plastic tip and following manufacturer's instructions. | Combination product | Test Group |
| Non-surgical periodontal treatment (NSPT)Full mouth supragingival professional mechanical plaque removal (PMPR) and subgingival PMPR at sites with PPD ≥4mm will be performed with the aid of manual and power-driven instruments under local anaesthesia. | Procedure or surgery | Control Group, Test Group |
Primary outcome
Changes in the expression of GCF wound healing biomarkers
Time frame: Baseline, 1, 7, 15, 30 days and 3 months following treatment
Changes in the expression of GCF wound healing biomarkers at 1, 7, 15, 30 days and 3 months following treatment will be assessed. A subset of analytes involved in the healing process and signalling pathways such as i) inflammation/immune response (e.g., IL-1 β, IL-1 α, IL-6, IL-8, IL-4, IL-10,IL-17, TNF- α, MMP-1, MMP-8, MMP-9, TIMP-1), ii) bone formation/resorption (e.g., TGF- β, osteocalcin, osteopontin, osteoprotegerin, BMP-2), iii) oxidative stress (e.g., Myeloperoxidase), and iv) angiogenesis (e.g., VEGF, angiopoietin-1) will be selected based on the pathways identified and optimized in the genomic and proteomic work from our group. Multiplex immunoassays will be designed specifically for quantitative analyses in the GCF for the 2 groups at the different time points.
13 secondary outcomes
Changes in the Blood flow
Time frame: Baseline and at 1, 7, 15, and 30 days following treatment.
Changes in the bacterial load
Time frame: Baseline and at 7, 15, 30 days and 3 months following treatment.
Changes in the probing pocket depth (PPD)
Time frame: Baseline and at 3 months after intervention
Changes in the gingival recession (REC)
Time frame: Baseline and at 3 months after intervention
Changes in the clinical attachment level (CAL)
Time frame: Baseline and at 3 months after intervention
Changes in the Full mouth plaque score (FMPS)
Time frame: Baseline and at 3 months after intervention
Changes in the Full mouth bleeding score (FMBS)
Time frame: Baseline and at 3 months after intervention
Changes in the suppuration
Time frame: Baseline and at 3 months after intervention
Soft tissues contour changes
Time frame: Baseline, 1, 7, 15, 30 days, and 3 months following treatment
Changes in the periodontal inflamed surface area (PISA)
Time frame: Baseline and at 3 months after intervention
Dentin hypersensitivity
Time frame: Baseline, 1, 7, 15, 30 days, and 3 months after procedure
Patient perception about therapy
Time frame: 1,7 and 15 days after procedure
Global changes in quality of life
Time frame: 3 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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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.
Jeniffer Perussolo, DDS, MS, PhD principal investigator
QMUL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA) and Octenidine gel and Non-surgical periodontal treatment (NSPT) in people with Periodontitis and Wound Heal, run by Queen Mary University of London at 2 sites in United Kingdom.
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 4 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miljana Bacevic, DDS, PhD (+44 02078823063, BHNT.Clinicaloralresearchcentre@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the expression of GCF wound healing biomarkers (time frame: Baseline, 1, 7, 15, 30 days and 3 months following treatment). 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 Feb 2026.