Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 312 for:    "Periodontitis, Chronic"

Decontaminant Agent in the Treatment of Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02657096
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Gaeasno Isola, University of Messina

Brief 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 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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Hybenx treatment (device) Procedure: Scaling and Root Planing (SRP) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Hybenx treatment
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.
Procedure: 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: Scaling and Root Planing (SRP)
The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.

Sham Comparator: Scaling and Root Planing
The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
Procedure: 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: Scaling and Root Planing (SRP)
The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.




Primary Outcome Measures :
  1. Probing depth (PD) [ Time Frame: At 365 days ]
    Measured clinically in mm using a periodontal probe during periodontal chart


Secondary Outcome Measures :
  1. Plaque and Gingival Crevicular Fluid [ Time Frame: At 365 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. good condition of general health,
  2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
  3. no involvement of the furcation,
  4. a minimum of a six teeth per quadrant, respectively.

Exclusion Criteria:

  1. periodontal therapy during the last 12 months,
  2. assumption of antibiotics during the last 6 months,
  3. pregnancy,
  4. any systemic condition which might affect the effects of the study treatment,
  5. previous or current radiation or immunosuppressive therapies,
  6. use of mouthwash containing antimicrobials during the previous 3 months,
  7. no use of hormonal contraceptives,
  8. medication by anti-inflammatory and immunosuppressive drugs,
  9. previous history of hard-drinking,
  10. smoking,
  11. class II and III tooth mobility.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657096


Sponsors and Collaborators
University of Messina
Investigators
Layout table for investigator information
Study Director: Giancarlo Cordasco, DDS University of Messina

Publications of Results:
Layout table for additonal information
Responsible Party: Dr. Gaeasno Isola, DDS,PhD Dr. Isola Gaetano, University of Messina
ClinicalTrials.gov Identifier: NCT02657096     History of Changes
Other Study ID Numbers: 918-10
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Gaeasno Isola, University of Messina:
Chronic Periodontitis
Hybenx
Desiccant agent
Healing
Microbiology
Periodontal Diseases
Periodontitis
Split-mouth clinical Study

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases