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Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical periodontal treatment with interdental hygiene devices
Non-surgical periodontal treatment without interdental hygiene devices
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Generalized chronic periodontitis (CP)
  • Generalized aggressive periodontitis (AgP)
  • Availability for non-surgical periodontal therapy and reevaluation after 3±1 months.
  • Moderate to advanced severity of periodontitis (≥30% of the sites with attachment loss ≥3mm)
  • Age: 18 - 70 years
  • ≥16 scorable teeth, without root caries

Exclusion Criteria:

  • Localized chronic or aggressive periodontitis (<30% diseased teeth of all teeth)
  • Smoking
  • Tumour(s) of the soft or hard tissues of the oral cavity.
  • Systematic disease, which include specific conditions to treat (e.g. prophylaxis of endocarditic)
  • Women who are aware of being pregnant or who are breastfeeding.
  • Forms of acute necrotizing ulcerating periodontitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Kiel Center

    Cairo Center

    Arm Description

    Non-surgical periodontal treatment with interdental hygiene devices in periodontitis patients.

    Non-surgical periodontal treatment without interdental hygiene devices in periodontitis patients.

    Outcomes

    Primary Outcome Measures

    Bleeding on probing
    Bleeding on probing (BOP) will be measured at least after the measurement of the CAL through recording bleeding sign at the site of clinical probing (six sites of each teeth).

    Secondary Outcome Measures

    Probing pocket depth
    Probing Pocket Depth (PPD) at every site will be assessed as the distance (mm) from the gingival margin to the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be inserted parallel to the root surface and directed apically toward the perceived location of the apex of the root until slight resistance is felt. Probe recordings will be rounded off to the nearest millimeter mark. PPDs are measured at six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
    Clinical attachment level (CAL)
    The CAL at every site will be measured as the distance between the cemento-enamel junction (CEJ) and the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be placed parallel to the tooth surface and probe recordings will be rounded off to the nearest millimeter mark. A score is given to six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
    Antibiotic use
    Measure whether antibiotics are used or not during the treatment phase by a questionnaire

    Full Information

    First Posted
    April 7, 2020
    Last Updated
    April 9, 2020
    Sponsor
    Cairo University
    Collaborators
    University of Kiel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04339309
    Brief Title
    Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
    Official Title
    Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University
    Collaborators
    University of Kiel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Periodontitis is treated by regularly clearance of the disease-causing biofilm through domestic care and dental measures (Petersilka et al., 2002, Herrera et al., 2008). Healthy gums have intact papillae occluding the interdental area. Successful brushing cleans these areas; the prophylaxis of gingivitis for such patients does therefore not require special aids. In contrast, initial attachment loss as a result of inflammation or restorative therapy leads to additional cleaning needs, since the normal brush is not able to clean interdental areas as successful as vestibular and oral surfaces (Dörfer and Staehle, 2010). It can be said that interdental brushes are the most effective tools for cleaning interdental spaces (Salzer et al., 2015). Compared with a toothbrush, they are the only tool showing better results of plaque removal and reduction of gingivitis (Slot et al., 2008). Therefore their use should not be restricted to older people with already reduced interdental papillae. A big advantage is that interdental brushes are generally easy to use. If brush sizes are chosen correctly, insertion and multiple forward and backward movement is sufficient to obtain com- plete cleaning of the interproximal surfaces. Additional cleaning by other means such as dental floss is not always necessary because interdental brushes clean approximal and subgingival surfaces sufficiently, providing the size was chosen correctly (Dörfer and Staehle, 2010). Due to the above mentioned coherences and associations, this study includes the hypothesis that patients with periodontitis would benefit from the instruction and motivation of interdental brushes within the active periodontitis therapy in comparison to a periodontitis therapy without the instructed domestic interdental hygiene by a stronger reduction of clinical inflammatory characteristics (Salzer et al., 2015). The corresponding Zero-Hypothesis says that no difference would be found between both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kiel Center
    Arm Type
    Active Comparator
    Arm Description
    Non-surgical periodontal treatment with interdental hygiene devices in periodontitis patients.
    Arm Title
    Cairo Center
    Arm Type
    Active Comparator
    Arm Description
    Non-surgical periodontal treatment without interdental hygiene devices in periodontitis patients.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical periodontal treatment with interdental hygiene devices
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical periodontal treatment without interdental hygiene devices
    Primary Outcome Measure Information:
    Title
    Bleeding on probing
    Description
    Bleeding on probing (BOP) will be measured at least after the measurement of the CAL through recording bleeding sign at the site of clinical probing (six sites of each teeth).
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    Probing Pocket Depth (PPD) at every site will be assessed as the distance (mm) from the gingival margin to the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be inserted parallel to the root surface and directed apically toward the perceived location of the apex of the root until slight resistance is felt. Probe recordings will be rounded off to the nearest millimeter mark. PPDs are measured at six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
    Time Frame
    3 months
    Title
    Clinical attachment level (CAL)
    Description
    The CAL at every site will be measured as the distance between the cemento-enamel junction (CEJ) and the apical end of the pocket using a PCP UNC-15 probe (Hu-Friedy, Chicago Ill, USA). The probe will be placed parallel to the tooth surface and probe recordings will be rounded off to the nearest millimeter mark. A score is given to six areas of the tooth. These are the disto-vestibular, vestibular, mesio-vestibular, disto-lingual, lingual and the mesio-lingual. First the vestibular surface is probed and scored. Thereafter, the lingual surface is probed and scored.
    Time Frame
    3 months
    Title
    Antibiotic use
    Description
    Measure whether antibiotics are used or not during the treatment phase by a questionnaire
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Generalized chronic periodontitis (CP) Generalized aggressive periodontitis (AgP) Availability for non-surgical periodontal therapy and reevaluation after 3±1 months. Moderate to advanced severity of periodontitis (≥30% of the sites with attachment loss ≥3mm) Age: 18 - 70 years ≥16 scorable teeth, without root caries Exclusion Criteria: Localized chronic or aggressive periodontitis (<30% diseased teeth of all teeth) Smoking Tumour(s) of the soft or hard tissues of the oral cavity. Systematic disease, which include specific conditions to treat (e.g. prophylaxis of endocarditic) Women who are aware of being pregnant or who are breastfeeding. Forms of acute necrotizing ulcerating periodontitis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16972401
    Citation
    Behle JH, Papapanou PN. Periodontal infections and atherosclerotic vascular disease: an update. Int Dent J. 2006 Aug;56(4 Suppl 1):256-62. doi: 10.1111/j.1875-595x.2006.tb00110.x.
    Results Reference
    background
    PubMed Identifier
    18724841
    Citation
    Herrera D, Alonso B, Leon R, Roldan S, Sanz M. Antimicrobial therapy in periodontitis: the use of systemic antimicrobials against the subgingival biofilm. J Clin Periodontol. 2008 Sep;35(8 Suppl):45-66. doi: 10.1111/j.1600-051X.2008.01260.x.
    Results Reference
    background
    PubMed Identifier
    16170976
    Citation
    Jared H, Zhong Y, Rowe M, Ebisutani K, Tanaka T, Takase N. Clinical trial of a novel interdental brush cleaning system. J Clin Dent. 2005;16(2):47-52.
    Results Reference
    background
    PubMed Identifier
    12013348
    Citation
    Petersilka GJ, Ehmke B, Flemmig TF. Antimicrobial effects of mechanical debridement. Periodontol 2000. 2002;28:56-71. doi: 10.1034/j.1600-0757.2002.280103.x.
    Results Reference
    background
    PubMed Identifier
    25581718
    Citation
    Salzer S, Slot DE, Van der Weijden FA, Dorfer CE. Efficacy of inter-dental mechanical plaque control in managing gingivitis--a meta-review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S92-105. doi: 10.1111/jcpe.12363.
    Results Reference
    background
    PubMed Identifier
    19138177
    Citation
    Slot DE, Dorfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):253-64. doi: 10.1111/j.1601-5037.2008.00330.x.
    Results Reference
    background

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    Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial

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