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Effect of Periodontitis Treatment on Quality of Life and Experiences of Fear, Anxiety and Pain

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Quadrant-wise scaling
Full-mouth 24-hour scaling
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, therapeutics, quality of life, fear, anxiety, pain

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mild to moderate chronic periodontitis
  • smokers or non-smokers
  • at least 18 natural teeth

Exclusion Criteria:

  • regular use or use in the previous 3 months of antibiotics or anti-inflammatory drugs
  • regular use (twice a day) of mouthwashes
  • sensitivity or allergy to oral hygiene products
  • patients undergoing periodontal therapy including dental scaling and root planing procedures in the 12 months preceding the start of the study
  • bifurcation or trifurcation class III lesions
  • the need for antibiotic prophylaxis for periodontal clinical examination/treatment
  • removable partial dentures, fixed or removable orthodontic devices
  • pregnancy and lactation
  • medical or psychological disorder that could affect the ability of the questionnaires' understanding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Quadrant-wise scaling

    Full-mouth 24-hour scaling

    Arm Description

    Patients underwent quadrant scaling under local anesthesia in four weekly sections.

    Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours.

    Outcomes

    Primary Outcome Measures

    Oral health related quality of life
    Scale of self-reported pain
    Fear and anxiety

    Secondary Outcome Measures

    Full Information

    First Posted
    March 30, 2015
    Last Updated
    July 19, 2019
    Sponsor
    University of Taubate
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02409966
    Brief Title
    Effect of Periodontitis Treatment on Quality of Life and Experiences of Fear, Anxiety and Pain
    Official Title
    Impact of Different Protocols for Treatment of Chronic Periodontitis on the Following Patient-centered Variables: Oral Health Related Quality of Life and Experiences of Fear, Anxiety and Pain: a 6 Month Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Taubate

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There are different protocols to treat gum diseases. One relevant differential aspect is related to time. There are protocols that usually takes one to two months to be completed while other are completed within 24 hours. Although both protocols seem to provide clinically similar improvements, there are some positive aspects related to the short-term one. Among them lower number of clinical sessions, easier schedule and costs advantages. However, there are many other relevant aspects that can be helpful for patients and clinicians decisions regarding type of treatment. This study evaluates if and how clinically effective protocols used to treat periodontitis affect quality of life related to individual's oral statuses. In addition, the experiences of fear, anxiety and pain before and after these specific protocols are monitored.
    Detailed Description
    Most randomized controlled clinical trials regarding the effects of non-surgical periodontal treatment have focused on objective parameters. Their effects on patient-centered variables have been received very little attention. After determining clinical therapeutic efficacy, this study compared over 6 months the effects of two different forms of non-surgical periodontal therapy - scaling and root planing per quadrant (SRP) and one-stage full-mouth disinfection (FMD) - on scores of quality of life, fear, anxiety and pain of moderate chronic periodontitis. Initially, the sample size was calculated considering protocols' clinical efficacy. Specifically for the present study it was verified if the initial sample size would be enough for analysis of the subjective variables. Patients registered in dental care centers from University of Taubate, Taubate - Sao Paulo, Brazil and Federal University of Minas Gerais, Belo Horizonte - Minas Gerais, Brazil were informed about the objectives and methods of the study, being consecutively included in the study only after signing an informed consent form. Selected participants were randomly allocated to one of the treatment groups by a closed envelope system. According to the designated group, participants receive either conventional quadrant scaling in four weekly sections or full-mouth scaling within 24 hours. Two experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files. Specific validated instruments were used to evaluate subjective variables. Oral Impacts on Daily Performance (OIDP) and Oral Health and Quality of Life (OHQoL-UK) measured quality of life while Dental Fear Survey (DFS), Dental Anxiety Scale (DAS) questionnaires and, Visual Analog Scale (VAS) measured experienced fear, anxiety and pain, respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    periodontitis, therapeutics, quality of life, fear, anxiety, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Quadrant-wise scaling
    Arm Type
    Active Comparator
    Arm Description
    Patients underwent quadrant scaling under local anesthesia in four weekly sections.
    Arm Title
    Full-mouth 24-hour scaling
    Arm Type
    Experimental
    Arm Description
    Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours.
    Intervention Type
    Procedure
    Intervention Name(s)
    Quadrant-wise scaling
    Intervention Description
    Patients underwent quadrant scaling under local anesthesia in four weekly sections. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files. Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study.
    Intervention Type
    Procedure
    Intervention Name(s)
    Full-mouth 24-hour scaling
    Intervention Description
    Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files. Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study.
    Primary Outcome Measure Information:
    Title
    Oral health related quality of life
    Time Frame
    changes in OIDP and OHQoL scores from baseline to 6 months
    Title
    Scale of self-reported pain
    Time Frame
    changes in VAS scores from baseline to 1 month
    Title
    Fear and anxiety
    Time Frame
    changes in DFS and DAS scores from baseline to 6 months
    Other Pre-specified Outcome Measures:
    Title
    Periodontal pocket depth (mm) and clinical attachment level (mm) were measure at baseline and at 6 months after active periodontal treatment.
    Time Frame
    from baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: mild to moderate chronic periodontitis smokers or non-smokers at least 18 natural teeth Exclusion Criteria: regular use or use in the previous 3 months of antibiotics or anti-inflammatory drugs regular use (twice a day) of mouthwashes sensitivity or allergy to oral hygiene products patients undergoing periodontal therapy including dental scaling and root planing procedures in the 12 months preceding the start of the study bifurcation or trifurcation class III lesions the need for antibiotic prophylaxis for periodontal clinical examination/treatment removable partial dentures, fixed or removable orthodontic devices pregnancy and lactation medical or psychological disorder that could affect the ability of the questionnaires' understanding

    12. IPD Sharing Statement

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