Decontaminant Agent in the Treatment of Chronic Periodontitis

NCT ID: NCT02657096

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hybenx treatment (device)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Scaling and Root Planing

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

Group Type: SHAM_COMPARATOR

Hybenx treatment (device)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Scaling and Root Planing (SRP)

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Messina

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gaeasno Isola

DDS,PhD Dr. Isola Gaetano

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giancarlo Cordasco, DDS

Role: STUDY_DIRECTOR

University of Messina

References

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.

Reference Type: RESULT

PMID: 26147153 (View on PubMed)

Other Identifiers

918-10

Identifier Type: -

Identifier Source: org_study_id