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

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, therapeutics, quality of life, fear, anxiety, pain
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
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
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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Effect of Periodontitis Treatment on Quality of Life and Experiences of Fear, Anxiety and Pain
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