NCT02657096

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
Last Updated

May 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

January 11, 2016

Last Update Submit

May 10, 2016

Conditions

Chronic Periodontitis

Keywords

Chronic PeriodontitisHybenxDesiccant agentHealingMicrobiologyPeriodontal DiseasesPeriodontitisSplit-mouth clinical Study

Outcome Measures

Primary Outcomes (1)

  • Probing depth (PD)

    Measured clinically in mm using a periodontal probe during periodontal chart

    At 365 days

Secondary Outcomes (1)

  • Plaque and Gingival Crevicular Fluid

    At 365 days

Study Arms (2)

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.

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.

Procedure: Hybenx treatment (device)Procedure: Scaling and Root Planing (SRP)

Interventions

Hybenx treatment (device)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.

Hybenx treatmentScaling and Root Planing
Scaling and Root Planing (SRP)PROCEDURE

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

Hybenx treatmentScaling and Root Planing

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • no use of hormonal contraceptives,
  • medication by anti-inflammatory and immunosuppressive drugs,
  • previous history of hard-drinking,
  • smoking,
  • class II and III tooth mobility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26147153RESULT

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal DiseasesPeriodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Giancarlo Cordasco, DDS

    University of Messina

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS,PhD Dr. Isola Gaetano

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 15, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

May 11, 2016

Record last verified: 2016-01