PeriodontitisNCT02409966
Effect of Periodontitis Treatment on Quality of Life and Experiences of Fear, Anxiety and Pain
A study testing Quadrant-wise scaling and Full-mouth 24-hour scaling in people with Periodontitis, run by University of Taubate.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Quadrant-wise scaling and Full-mouth 24-hour scaling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild to moderate chronic periodontitis
- smokers or non-smokers
- at least 18 natural teeth
Who cannot join
- 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
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- removable partial dentures, fixed or removable orthodontic devices
- pregnancy and lactation
- medical or psychological disorder that could affect the ability of the questionnaires' understanding
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Quadrant-wise scaling, Full-mouth 24-hour scaling
- Keywords
- periodontitis, therapeutics, quality of life, fear, anxiety, pain
- Medical subject headings
- Periodontitis, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrant-wise scalingProcedure or surgery
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.
Full-mouth 24-hour scalingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadrant-wise scaling | Active comparator | Patients underwent quadrant scaling under local anesthesia in four weekly sections. Receives: Procedure: Quadrant-wise scaling |
| Full-mouth 24-hour scaling | Experimental | Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours. Receives: Procedure: Full-mouth 24-hour scaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health related quality of life
Measured: changes in OIDP and OHQoL scores from baseline to 6 months
Scale of self-reported pain
Measured: changes in VAS scores from baseline to 1 month
Fear and anxiety
Measured: changes in DFS and DAS scores from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Taubate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409966
- Sponsor's protocol ID
- 552264/2011-3
- Other IDs
- 521-10, CAAE 07172212.3.0000.514
- Status last verified
- Jul 2019
- First submitted
- 30 Mar 2015
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02409966
- Acronym / sponsor ID
- 552264/2011-3
- Conditions
- Periodontitis
- Keywords
- periodontitis, therapeutics, quality of life, fear, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of TaubateUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrant-wise scaling | Active comparator | Procedure: Quadrant-wise scalingPatients underwent quadrant scaling under local anesthesia in four weekly sections. |
| Full-mouth 24-hour scaling | Experimental | Procedure: Full-mouth 24-hour scalingPatients underwent full-mouth scaling under local anesthesia in two sections within 24 hours. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mild to moderate chronic periodontitis
- smokers or non-smokers
- at least 18 natural teeth
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrant-wise scalingPatients 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. | Procedure or surgery | Quadrant-wise scaling |
| Full-mouth 24-hour scalingPatients 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. | Procedure or surgery | Full-mouth 24-hour scaling |
Primary outcome
Oral health related quality of life
Time frame: changes in OIDP and OHQoL scores from baseline to 6 months
Scale of self-reported pain
Time frame: changes in VAS scores from baseline to 1 month
Fear and anxiety
Time frame: changes in DFS and DAS scores from baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Quadrant-wise scaling and Full-mouth 24-hour scaling in people with Periodontitis, run by University of Taubate.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health related quality of life (time frame: changes in OIDP and OHQoL scores from baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.