ParodontitisSFYCTNCT05975177
Evaluation of the Efficacy of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing
A study testing Sterify Gel and Scaling and root planing in people with Parodontitis, run by Sterify S.r.l. at 1 site in Italy.
Trial summary
The purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure, in terms of periodontal pocket healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parodontitis
- What is being tested?
- Sterify Gel and Scaling and root planing
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2022to 6 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with grade III and IV chronic periodontal disease according to the European Federation of Periodontology classification involving at least two sites
- Adherence to the study and signing of informed consent
- Major age- Participants with a minimum of 6 teeth with periodontal pocket depth greater than 5mm- Participants with at least 20 teeth
Who cannot join
- Established hypersensitivity to one or more components of the device- Pregnancy or lactation- Heavy smoker (more than 9 cigarettes per day)- Concomitant dental disease, except periodontitis, or planned treatment that may interfere with the study or study procedure, such as dental surgery or tooth implantation- Diabetes mellitus, rheumatoid arthritis, or other chronic diseases that may affect disease or treatment
- Aggressive periodontitis
- History of radiation or chemotherapy
- Autoimmune mucosal diseases
- Mental illnesses
- Parafunctions such as bruxism
- Use of antibiotics in the past 3 months
- Periodontal surgeries in the past 12 months in the areas covered by the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing: Pivotal, Prospective, Single-center, Split-mouth, Randomized, Controlled Study
The purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure, in terms of periodontal pocket healing. Efficacy will be compared with the use of the nonsurgical SRP technique alone, which is considered a gold standard treatment for periodontitis, with the aim of observing improved results when using the STERIFY GEL device.
The study is prospective, split-mouth.STERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP, with the contralateral segments serving as controls (split-mouth), in a single session.
Read the detailed description
The purpose of the study is to test the safety and efficacy of STERIFY GEL in promoting healing of periodontal pockets following SRP, compared with treatment with SRP alone. With specific visco-elastic and mucoadhesive properties, STERIFY GEL easily penetrates into the deepest and hard-to-reach areas of periodontal and peri-implant pockets, adhering to the gingival tissue and alveolar bone, providing complete coverage of the pockets. The effect of STERIFY GEL is promoted by a physical mechanism of action. After SRP, the gel is applied into the gingival pocket, where it acts primarily as a filler to restore volume, physically preventing bacteria from entering and reinfecting the pocket. STERIFY GEL can thus mechanically protect treated pockets and bone defects, promoting tissue healing. The occluding action at the level of periodontal and peri-implant gingival pockets, in synergy with the accessory action of hydroxytyrosol, nisin, and magnesium ascorbyl phosphate, prevents bacterial recolonization and promotes subsequent tissue regeneration.
Although SRP surgery is considered a gold standard treatment for periodontitis, it may in some cases be insufficient to decontaminate the pocket allowing bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical picture.STERIFY GEL may find useful application in cases of moderate to severe chronic periodontal disease as an adjunctive treatment following SRP to improve and accelerate healing parameters and prevent recurrent inflammation and infection.In addition, antimicrobial control action prevents antibiotic use and the risk associated with antibiotic resistance.Such control of periodontal disease also allows for the maintenance of patients who cannot undergo surgical treatment (e.g., patients on bisphosphonate therapy, defected etc.).
- Conditions
- Parodontitis
- Being tested
- Sterify Gel, Scaling and root planing
- Keywords
- Sterify gel, periodontal disease, periodontal pockets, scaling and root planing, oral health, dental care
- Medical subject headings
- Dry Socket, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterify GelDevice
A mucoadhesive polymeric hydrogel in a prefilled syringe for nonsurgical treatment of periodontal and peri-implant pockets, composed of polyvinyl polymers, hydroxytyrosol, nisin, and magnesium ascorbyl phosphate
Scaling and root planingProcedure or surgery
The non-surgical procedure involved SRP under local anesthesia with EMS scalers and Gracey curettes.
| Study group | Role | What they receive |
|---|---|---|
| Sterify Gel + SRP | Experimental | Scaling and root planing in the assigned site, followed by intra-pocket administration of Sterify Gel, applied to the bottom of the pocket until the gel emerges or becomes visible at the gingival margin Receives: Device: Sterify Gel; Procedure: Scaling and root planing |
| SRP only | Active comparator | Scaling and root planing in the assigned site. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Depth
Measurement by periodontal probe of periodontal pocket depth. Unit of measurement in mm with a sensitivity of 0.5 mm.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Secondary outcomes (7)
Gingival recession
Measurement by periodontal probe of the distance from the cemento-enamel junction to the depth of the free gingival margin.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Clinical Attachment Level
Measurement by periodontal probe of the distance in millimeters between the amelo-cement junction (the boundary between the crown and root of the tooth) and the bottom of the pocket.It can also be calculated by summing the gingival recession and the periodontal pocket.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Plaque Index
The plaque index (PI) (Silness J \& Löe H), is recorded, during the clinical periodontal examination, at 4 to 6 sites for each tooth element present by circumferential probing with a manual periodontal probe.The 6 dental sites considered are: buccal, mesio-buccal, disto-buccal, lingual, mesio-lingual, and disto-lingual (if there are 4: distal, proximal, palatine/lingual, buccal).Each site is given a score from 0 to 3, where: 0 no plaque, 3 abundance of plaque.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Bleeding Index
% measurement. Each site is gently probed with a periodontal probe at six sites (mesial, middle, and distal on both buccal and lingual surfaces): bleeding is assessed as present or absent, and the number of sites where bleeding is present is recorded.The number of sites where bleeding is recorded is divided by the total number of sites available in the mouth and multiplied by 100 to express the bleeding index as a percentage.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Furcations
0: no furcation1: horizontal loss of supporting tissues not exceeding one third of the tooth width 2: horizontal loss of supporting tissues exceeding one-third of the tooth width but not affecting the entire furcation 3: Horizontal loss of supporting tissues "passing through" the entire furcation area.
Measured: Pre-treatment, 1 month, 2 months, 3 months
Grade of Mobility
The survey of dental mobility completes the objective examination. It is important to remember that mobility can be periodontal, traumatic, or endodontic in origin and should be assessed by the application of slight forces conveyed through two instruments and not with the fingers.
Class 0: physiological mobility.Class 1: slightly increased mobility, slight horizontal displacements (Perceptible mobility <1mm in buccolingual direction) Class 2: markedly increased mobility without functional impediment, displacements in horizontal direction (>1mm but <2mm) Class 3: markedly increased mobility with functional impediment, displacements even in vertical direction (>2mm or depressibility in the socket)
Measured: Pre-treatment, 1 month, 2 months, 3 months
Quantification of bacterial contamination
Bacterial contamination assessed through quantitative PCR.
Measured: Pre-treatment, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start3 Dec 2022
- Primary completion11 Mar 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParodontitisStudies 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 study is a split-mouth study. STERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP, with the contralateral segments serving as controls (split-mouth), in a single session.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sterify S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sciently di Omar Sabry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975177
- Sponsor's protocol ID
- SFYCT
- Acronym
- SFYCT
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing: Pivotal, Prospective, Single-center, Split-mouth, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05975177
- Acronym / sponsor ID
- SFYCT / SFYCT
- Conditions
- Parodontitis
- Keywords
- Sterify gel, periodontal disease, periodontal pockets, scaling and root planing, oral health, dental care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sterify S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Sciently di Omar Sabry
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 3 Aug 2023 (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 purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure, in terms of periodontal pocket healing. Efficacy will be compared with the use of the nonsurgical SRP technique alone, which is considered a gold standard treatment for periodontitis, with the aim of observing improved results when using the STERIFY GEL device.
The study is prospective, split-mouth.STERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP, with the contralateral segments serving as controls (split-mouth), in a single session.
Detailed description
The purpose of the study is to test the safety and efficacy of STERIFY GEL in promoting healing of periodontal pockets following SRP, compared with treatment with SRP alone. With specific visco-elastic and mucoadhesive properties, STERIFY GEL easily penetrates into the deepest and hard-to-reach areas of periodontal and peri-implant pockets, adhering to the gingival tissue and alveolar bone, providing complete coverage of the pockets. The effect of STERIFY GEL is promoted by a physical mechanism of action. After SRP, the gel is applied into the gingival pocket, where it acts primarily as a filler to restore volume, physically preventing bacteria from entering and reinfecting the pocket. STERIFY GEL can thus mechanically protect treated pockets and bone defects, promoting tissue healing. The occluding action at the level of periodontal and peri-implant gingival pockets, in synergy with the accessory action of hydroxytyrosol, nisin, and magnesium ascorbyl phosphate, prevents bacterial recolonization and promotes subsequent tissue regeneration.
Although SRP surgery is considered a gold standard treatment for periodontitis, it may in some cases be insufficient to decontaminate the pocket allowing bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical picture.STERIFY GEL may find useful application in cases of moderate to severe chronic periodontal disease as an adjunctive treatment following SRP to improve and accelerate healing parameters and prevent recurrent inflammation and infection.In addition, antimicrobial control action prevents antibiotic use and the risk associated with antibiotic resistance.Such control of periodontal disease also allows for the maintenance of patients who cannot undergo surgical treatment (e.g., patients on bisphosphonate therapy, defected etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a split-mouth study. STERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP, with the contralateral segments serving as controls (split-mouth), in a single session.
| Arm | Type | Receives |
|---|---|---|
| Sterify Gel + SRP | Experimental | Device: Sterify Gel, Procedure: Scaling and root planingScaling and root planing in the assigned site, followed by intra-pocket administration of Sterify Gel, applied to the bottom of the pocket until the gel emerges or becomes visible at the gingival margin |
| SRP only | Active comparator | Procedure: Scaling and root planingScaling and root planing in the assigned site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with grade III and IV chronic periodontal disease according to the European Federation of Periodontology classification involving at least two sites
- Adherence to the study and signing of informed consent
- Major age- Participants with a minimum of 6 teeth with periodontal pocket depth greater than 5mm- Participants with at least 20 teeth
Key exclusion criteria (8 listed)
- Established hypersensitivity to one or more components of the device- Pregnancy or lactation- Heavy smoker (more than 9 cigarettes per day)- Concomitant dental disease, except periodontitis, or planned treatment that may interfere with the study or study procedure, such as dental surgery or tooth implantation- Diabetes mellitus, rheumatoid arthritis, or other chronic diseases that may affect disease or treatment
- Aggressive periodontitis
- History of radiation or chemotherapy
- Autoimmune mucosal diseases
- Mental illnesses
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 |
|---|---|---|
| Sterify GelA mucoadhesive polymeric hydrogel in a prefilled syringe for nonsurgical treatment of periodontal and peri-implant pockets, composed of polyvinyl polymers, hydroxytyrosol, nisin, and magnesium ascorbyl phosphate | Device | Sterify Gel + SRP |
| Scaling and root planingThe non-surgical procedure involved SRP under local anesthesia with EMS scalers and Gracey curettes. | Procedure or surgery | SRP only, Sterify Gel + SRP |
Primary outcome
Pocket Depth
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Measurement by periodontal probe of periodontal pocket depth. Unit of measurement in mm with a sensitivity of 0.5 mm.
7 secondary outcomes
Gingival recession
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Clinical Attachment Level
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Plaque Index
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Bleeding Index
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Furcations
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Grade of Mobility
Time frame: Pre-treatment, 1 month, 2 months, 3 months
Quantification of bacterial contamination
Time frame: Pre-treatment, 3 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 7 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterify Gel and Scaling and root planing in people with Parodontitis, run by Sterify S.r.l. 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 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 7 Aug 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?
Pocket Depth (time frame: Pre-treatment, 1 month, 2 months, 3 months). 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 7 Aug 2023.