Gingival HemorrhageNCT02725983
Intra-oral Camera in Gingival Health
A study testing SPT consultation and SOPROCARE® in people with Gingival Hemorrhage and Gingivitis, run by University of Lisbon.
Trial summary
Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Hemorrhage, Gingivitis, Health Behavior
- What is being tested?
- SPT consultation and SOPROCARE®
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old.
- + 20 teeth (minimum 5 per quadrant)
- BOMP > 0.5
Who cannot join
- periodontitis (pockets >4),
- smoking patients
- orthodontic patients
- pregnant
- 1 removable partial denture
About this study
Official title: Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis
Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.
Read the detailed description
A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control.
Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy and planning) and IOC opinion were evaluated one week before or during the consultation and four months later.
- Conditions
- Gingival Hemorrhage, Gingivitis, Health Behavior, Communication
- Being tested
- SPT consultation, SOPROCARE®
- Keywords
- Gingivitis, Oral Hygiene, Intra oral camera, Self regulation, bleeding
- Medical subject headings
- Gingival Hemorrhage, Gingivitis, Health Behavior, Communication, Self-Control, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPT consultationBehavioural
SOPROCARE®Device
| Study group | Role | What they receive |
|---|---|---|
| Intra Oral Camera | Experimental | Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills. Receives: Behavioral: SPT consultation; Device: SOPROCARE® |
| No Intra Oral camera | Active comparator | Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015) and considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon was not used. Receives: Behavioral: SPT consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).
In this index, bleeding is scored during 30 seconds of probing using a 3 point scale from 0 to 2 (0 - no bleeding, 1 - point bleeding, 2 - excess bleeding).
Measured: Baseline to 4 months
Secondary outcomes (2)
Dental Hygiene (Flossing and tooth-brushing habits)
In order to assess dental hygiene, two questions were asked on brushing and flossing habits. Individual scores for brushing and flossing were calculated and a composite score was also computed for both (referred to as Dental Hygiene). A 5 point Likert-scale was used. Item example: In the last two weeks/four months how often have you flossed your teeth?
Measured: Baseline to 4 months
Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)
Measures adapted to oral health from previous studies with the HAPA model (Godinho et al. 2015) were used. All the psychological variables were evaluated using a 7 point Likert-type scale, ranging from totally disagree (1) to totally agree (7).
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gingival HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Psicologia
- Responsible party
- Principal investigator, Mario Rui Araújo, University of Lisbon
- Investigators
- Maria-João Maria-João, PhD, Principal investigator, Faculdade de Psicologia da Universidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725983
- Sponsor's protocol ID
- 06/2014
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
PubMed 7806674Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Health messages to promote fruit and vegetable consumption at different stages: A match-mismatch design. Psychol Health. 2015;30(12):1410-32. doi: 10.1080/08870446.2015.1054827. Epub 2015 Jul 24.
PubMed 26010304Bardet P, Suvan J, Lang NP. Clinical effects of root instrumentation using conventional steel or non-tooth substance removing plastic curettes during supportive periodontal therapy (SPT). J Clin Periodontol. 1999 Nov;26(11):742-7. doi: 10.1034/j.1600-051x.1999.t01-6-261101.x.
PubMed 10589810Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.
PubMed 25639708
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological, Behavioral and Clinical Effects of Intra Oral Camera: a Randomized Control Trial on Adults With Gingivitis
- ClinicalTrials.gov ID
- NCT02725983
- Acronym / sponsor ID
- 06/2014
- Conditions
- Gingival Hemorrhage, Gingivitis, Health Behavior, Communication
- Keywords
- Gingivitis, Oral Hygiene, Intra oral camera, Self regulation, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Collaborators
- Faculdade de Psicologia
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Apr 2016 (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.
Evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.
Detailed description
A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control.
Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy and planning) and IOC opinion were evaluated one week before or during the consultation and four months later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra Oral Camera | Experimental | Behavioral: SPT consultation, Device: SOPROCARE®Dental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015). Special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation). In this group, the device SOPROCARE® by Acteon was used in the examination and diagnosis and also for the establishment of therapeutic goals, strategies and skills. |
| No Intra Oral camera | Active comparator | Behavioral: SPT consultationDental appointment, one hour and included activities that are normally part of a SPT consultation (Bardet et al. 1999), as well as specific behavior change techniques, such as the use of reinforcement, goal-setting and feedback as described by Newton and Asimakopoulou (2015) and considered crucial to the accomplishment of long term behavior change. Moreover, special attention was given to patient communication and words such as 'cleaning' and 'hygiene' were replaced by therapeutic synonyms (e.g. inflamed areas and controlling the inflammation) in order to focus patients´ attention on the varied facets of oral health care and increase their perception of the treatment needs. In this group, the device SOPROCARE® by Acteon was not used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old.
- + 20 teeth (minimum 5 per quadrant)
- BOMP > 0.5
Key exclusion criteria (5 listed)
- periodontitis (pockets >4),
- smoking patients
- orthodontic patients
- pregnant
- 1 removable partial denture
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 |
|---|---|---|
| SPT consultation | Behavioural | Intra Oral Camera, No Intra Oral camera |
| SOPROCARE® | Device | Intra Oral Camera |
Primary outcome
The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994).
Time frame: Baseline to 4 months
In this index, bleeding is scored during 30 seconds of probing using a 3 point scale from 0 to 2 (0 - no bleeding, 1 - point bleeding, 2 - excess bleeding).
2 secondary outcomes
Dental Hygiene (Flossing and tooth-brushing habits)
Time frame: Baseline to 4 months
Measuring Health Behavior Change: Health Action Process Approach Model (HAPA, Schwarzer, 2008)
Time frame: Baseline to 4 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 1 Apr 2016.
- Background: PubMed 7806674Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.
- Background: PubMed 26010304Godinho CA, Alvarez MJ, Lima ML, Schwarzer R. Health messages to promote fruit and vegetable consumption at different stages: A match-mismatch design. Psychol Health. 2015;30(12):1410-32. doi: 10.1080/08870446.2015.1054827. Epub 2015 Jul 24.
- Background: PubMed 10589810Bardet P, Suvan J, Lang NP. Clinical effects of root instrumentation using conventional steel or non-tooth substance removing plastic curettes during supportive periodontal therapy (SPT). J Clin Periodontol. 1999 Nov;26(11):742-7. doi: 10.1034/j.1600-051x.1999.t01-6-261101.x.
- Background: PubMed 25639708Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.
- Individual participant dataSharing planned: No
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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.
Maria-João Maria-João, PhD principal investigator
Faculdade de Psicologia da Universidade de Lisboa
Questions about this trial
What is this clinical trial studying?
A study testing SPT consultation and SOPROCARE® in people with Gingival Hemorrhage and Gingivitis, run by University of Lisbon.
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 5 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 1 Apr 2016. 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?
The gingival condition was assessed using the BOMP (Bleeding on Marginal Probing) index , as described by Van der Weijden et al. (1994). (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725983, which also lists 4 linked publications.
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 1 Apr 2016.