Chronic PeriodontitisNCT02657096
Decontaminant Agent in the Treatment of Chronic Periodontitis
A study testing Hybenx treatment (device) and Scaling and Root Planing (SRP) in people with Chronic Periodontitis, run by University of Messina.
Trial summary
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Chronic Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the post-treatment clinical parameters and immunological and… Read more about this study
- Who is it for?
- Ages 18 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Hybenx treatment (device) and Scaling and Root Planing (SRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2015
- 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 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good condition of general health,
- a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
- no involvement of the furcation,
- a minimum of a six teeth per quadrant, respectively.
Who cannot join
- periodontal therapy during the last 12 months,
- assumption of antibiotics during the last 6 months,
- pregnancy,
- any systemic condition which might affect the effects of the study treatment,
- previous or current radiation or immunosuppressive therapies,
- use of mouthwash containing antimicrobials during the previous 3 months,
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- no use of hormonal contraceptives,
- medication by anti-inflammatory and immunosuppressive drugs,
- previous history of hard-drinking,
- smoking,
- class II and III tooth mobility.
About this study
Official title: Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Chronic Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with CP, treated by either SRP in addition to desiccant or SRP alone.
The null hypothesis to invalidate was that, after a one year follow-up, there were no variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between SRP + desiccant and SRP alone treatment.
Read the detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of CP (Chronic Periodontitis) were enrolled in this clinical trial.
Study design Thirty-six patients, 19 men and 17 women, aged 27 to 65 (mean age 46.7) were assessed for eligibility at the Department of Biomedical, Odontostomatological Sciences and Morphological and Functional Images at the University of Messina, Messina, Italy. This trial was conducted in agreement with the CONSORT guidelines.
In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.
To permit the noninvasive specimen, all the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point present in the commercial kit† introduced into the base of the selected site for 30 s, a subgingival plaque sample was collected.
The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different non-contiguous interproximal sites using filter paper strips‡ as previously described. The levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent assay using an equation with software using a five polynomial parameter.
Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP) + desiccant (Hybenx), while the contra-lateral quadrants were treated as conventional SRP alone.
- Conditions
- Chronic Periodontitis
- Being tested
- Hybenx treatment (device), Scaling and Root Planing (SRP)
- Keywords
- Chronic Periodontitis, Hybenx, Desiccant agent, Healing, Microbiology, Periodontal Diseases, Periodontitis, Split-mouth clinical Study
- Medical subject headings
- Chronic Periodontitis, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybenx treatment (device)Procedure or surgery
In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution.
Scaling and Root Planing (SRP)Procedure or surgery
The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
| Study group | Role | What they receive |
|---|---|---|
| Hybenx treatment | Experimental | Both quadrants included maxillary teeth 11-16 and 21-26. Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional SRP + desiccant (Hybenx). In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the marginal gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution. Receives: Procedure: Hybenx treatment (device); Procedure: Scaling and Root Planing (SRP) |
| Scaling and Root Planing | Sham comparator | The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone. Receives: Procedure: Hybenx treatment (device); Procedure: Scaling and Root Planing (SRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth (PD)
Measured clinically in mm using a periodontal probe during periodontal chart
Measured: At 365 days
Secondary outcomes (1)
Plaque and Gingival Crevicular Fluid
All the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point gently introduced into the base of the selected site for 30 s, a subgingival plaque and Gingival Crevicular Fluid sample was collected. Number of participants with treatment-related adverse events as assessed by enzyme-linked immunosorbent assay and the checkerboard DNA-DNA hybridization technique were used in order to check the secondary outcome.
Measured: At 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionSep 2015
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 Chronic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gaeasno Isola, University of Messina
- Investigators
- Giancarlo Cordasco, DDS, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657096
- Sponsor's protocol ID
- 918-10
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lombardo G, Signoretto C, Corrocher G, Pardo A, Pighi J, Rovera A, Caccuri F, Nocini PF. A topical desiccant agent in association with ultrasonic debridement in the initial treatment of chronic periodontitis: a clinical and microbiological study. New Microbiol. 2015 Jul;38(3):393-407. Epub 2015 Jul 6.
PubMed 26147153
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study
- ClinicalTrials.gov ID
- NCT02657096
- Acronym / sponsor ID
- 918-10
- Conditions
- Chronic Periodontitis
- Keywords
- Chronic Periodontitis, Hybenx, Desiccant agent, Healing, Microbiology, Periodontal Diseases, Periodontitis, Split-mouth clinical Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jan 2016 (estimated)
- 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.
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Chronic Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with CP, treated by either SRP in addition to desiccant or SRP alone.
The null hypothesis to invalidate was that, after a one year follow-up, there were no variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between SRP + desiccant and SRP alone treatment.
Detailed description
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent. Subjects with a diagnosis of CP (Chronic Periodontitis) were enrolled in this clinical trial.
Study design Thirty-six patients, 19 men and 17 women, aged 27 to 65 (mean age 46.7) were assessed for eligibility at the Department of Biomedical, Odontostomatological Sciences and Morphological and Functional Images at the University of Messina, Messina, Italy. This trial was conducted in agreement with the CONSORT guidelines.
In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.
To permit the noninvasive specimen, all the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point present in the commercial kit† introduced into the base of the selected site for 30 s, a subgingival plaque sample was collected.
The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different non-contiguous interproximal sites using filter paper strips‡ as previously described. The levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent assay using an equation with software using a five polynomial parameter.
Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP) + desiccant (Hybenx), while the contra-lateral quadrants were treated as conventional SRP alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybenx treatment | Experimental | Procedure: Hybenx treatment (device), Procedure: Scaling and Root Planing (SRP)Both quadrants included maxillary teeth 11-16 and 21-26. Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional SRP + desiccant (Hybenx). In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the marginal gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution. |
| Scaling and Root Planing | Sham comparator | Procedure: Hybenx treatment (device), Procedure: Scaling and Root Planing (SRP)The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- good condition of general health,
- a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
- no involvement of the furcation,
- a minimum of a six teeth per quadrant, respectively.
Key exclusion criteria (11 listed)
- periodontal therapy during the last 12 months,
- assumption of antibiotics during the last 6 months,
- pregnancy,
- any systemic condition which might affect the effects of the study treatment,
- previous or current radiation or immunosuppressive therapies,
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 |
|---|---|---|
| Hybenx treatment (device)In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution. | Procedure or surgery | Hybenx treatment, Scaling and Root Planing |
| Scaling and Root Planing (SRP)The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone. | Procedure or surgery | Hybenx treatment, Scaling and Root Planing |
Primary outcome
Probing depth (PD)
Time frame: At 365 days
Measured clinically in mm using a periodontal probe during periodontal chart
1 secondary outcome
Plaque and Gingival Crevicular Fluid
Time frame: At 365 days
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 11 May 2016.
- Results publication: PubMed 26147153Lombardo G, Signoretto C, Corrocher G, Pardo A, Pighi J, Rovera A, Caccuri F, Nocini PF. A topical desiccant agent in association with ultrasonic debridement in the initial treatment of chronic periodontitis: a clinical and microbiological study. New Microbiol. 2015 Jul;38(3):393-407. Epub 2015 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Giancarlo Cordasco, DDS study director
University of Messina
Questions about this trial
What is this clinical trial studying?
A study testing Hybenx treatment (device) and Scaling and Root Planing (SRP) in people with Chronic Periodontitis, run by University of Messina.
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 11 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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) (time frame: At 365 days). 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 NCT02657096, 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 11 May 2016.