Motivational InterviewingNCT04871373
Motivational Interview and Orthodontic Patients
A study testing Motivational interviewing and Oral Hygiene Instructions in people with Motivational Interviewing and Oral Hygiene, run by Universidad Iberoamericana at 1 site in Dominican Republic.
Trial summary
A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing, Oral Hygiene, Orthodontic Appliance Complication
- What is being tested?
- Motivational interviewing and Oral Hygiene Instructions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDominican Republic
- Study dates
- 16 Jun 2017to 12 Nov 2018
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with 18-40 years old, systemically healthy, without active dental caries lesions or periodontal diseases, who were candidates for fixed orthodontic appliances.
Who cannot join
- Smokers and pregnant patients.
- Participants were discarded if they decided voluntarily to abandon the study of the orthodontic treatment or if they didn't attend to the periodical check-ups.
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Universidad Iberoamericana UNIBE
Santo Domingo, Nacional, 22333
About this study
Official title: The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances: A Randomised Clinical Trial
A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison with conventional oral hygiene instructions alone.
A computer-generated list of numbers created with Statistical Package for the Social Sciences (SPSS) V21.0 was used to random allocate participants into the experimental or the control group. Monthly oral hygiene instructions and a G.U.M. kit were given to the sample. Additionally, the experimental group received motivational interviewing sessions by a trained periodontist. Simplified Oral Hygiene Index, Gingival Index, Periodontal Probing Depth and Bleeding on Probing were recorded at baseline, three and six months after the beginning of the study. Repeated-measures analysis of variance and chi-squared test were conducted.
Read the detailed description
Sample calculation A power analysis was carried out to determine the number of subjects needed to achieve a Simplified Oral Hygiene Index (SOHI) significant interaction with the study groups when applying repeated measures ANOVA. The total number of completed subjects needed to achieve power of 0.90 with an alpha (α) of 0.05, an effect size (f) of at least .25 was determined to be 36; taking into consideration a possible 10% attrition rate, 45 subjects were recruited, consented and randomized to either the experimental or control group.
Due to the matter that repeated measures ANOVA treats each measurement as a separate variable, and it's preferable to use listwise deletion, if one measurement is missing, the whole case gets dropped. For this reason and therefore the incontrovertible fact that the trial suffers attrition, the sample for the three measurements was reduced to 32 subjects.
Randomization A simple randomization procedure was executed by the principal investigator to allocate the participants into one of the study groups. A computer-generated list of numbers was created using the software SPSS V21.0, with a 1:1.25 allocation ratio.
Two dentists enrolled and allocated the participants according to the order of arrival and following the list of random numbers. A coding system was used as a concealment mechanism, which consisted of colored labels attached to the participants' file. Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.
Study intervention An interviewer was in charge of providing oral hygiene instructions for both groups. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Then, the patients of the experimental group received a motivational interviewing session.
Afterward, the clinical parameters were measured by another periodontist. Monthly follow-up appointments were scheduled for the orthodontic check-ups to deliver a new G.U.M. kit, to reinforce the OHI and MI, and to register the periodontal parameters. The important data for this research was the one recorded at baseline, three and six months after the intervention.
Statistical analysis Mean Simplify oral hygiene index (SOHI), gingival index (GI), periodontal probing depth (PPD), and bleeding on probing (BoP) scores were compared between groups across three-time points using repeated-measures mixed-model analysis of variance. Tests for equality of variances and sphericity to check for homoscedasticity were performed due to the problem of sample attrition. Nevertheless, it was not found any violation to these assumptions in any of the variables included in the analysis. SPSS software was used for all calculations (IBM SPSS 25th version). Due to the nominal level of measurement of the variable BoP, it was performed a chi-squared test for each three time points to check if there were any differences between the two experimental conditions.
- Being tested
- Motivational interviewing, Oral Hygiene Instructions
- Keywords
- Motivational interviewing, Oral hygiene, Fixed orthodontic appliances, Treatment adherence
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Also called Motivational interview
A periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group.
Oral Hygiene InstructionsBehavioural
Also called OHI
A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A trained periodontist delivered oral hygiene instructions and motivational interviewing sessions. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Receives: Behavioral: Motivational interviewing; Behavioral: Oral Hygiene Instructions |
| Control group | Active comparator | A trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Receives: Behavioral: Oral Hygiene Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Oral Hygiene Index
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Measured: Base line.
Simplified Oral Hygiene Index
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Measured: 3rd month
Simplified Oral Hygiene Index
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Measured: 6th month
Secondary outcomes (3)
Gingival Index
Each of the four gingival areas of the tooth is given a score from 0 to 3; this is the gingival índex for the area.
Measured: Base line, 3 and 6 months after the intervention.
Periodontal Probing Depth
One tooth per sextant was chosen and the average was calculated.
Measured: Base line, 3 and 6 months after the intervention.
Bleeding on Probing
Dichotomic response after probing the gingival sulcus.
Measured: Base line, 3 and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start16 Jun 2017
- Primary completion12 Nov 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies 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
- Model description
- Orthodontic patients were recruited to be divided into a control group (that received oral hygiene instructions) and an experimental group (that received oral hygiene instructions and motivational interviewing sessions).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Iberoamericana
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios Collado
- Responsible party
- Sponsor
- Investigators
- Henry A Adames, MsC, Principal investigator, Universidad Iberoamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871373
- Sponsor's protocol ID
- CEI2017-06
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yavan MA, Kocahan S, Ozdemir S, Sokucu O. The Effects of Using Plaque-Disclosing Tablets on the Removal of Plaque and Gingival Status of Orthodontic Patients. Turk J Orthod. 2019 Dec 1;32(4):207-214. doi: 10.5152/TurkJOrthod.2019.18084. eCollection 2019 Dec.
PubMed 32110465Alstad S, Zachrisson BU. Longitudinal study of periodontal condition associated with orthodontic treatment in adolescents. Am J Orthod. 1979 Sep;76(3):277-86. doi: 10.1016/0002-9416(79)90024-1. No abstract available.
PubMed 290273Petrauskiene S, Wanczewska N, Slabsinskiene E, Zemgulyte G. Self-Reported Changes in Oral Hygiene Habits among Adolescents Receiving Orthodontic Treatment. Dent J (Basel). 2019 Oct 1;7(4):96. doi: 10.3390/dj7040096.
PubMed 31581420Arici S, Alkan A, Arici N. Comparison of different toothbrushing protocols in poor-toothbrushing orthodontic patients. Eur J Orthod. 2007 Oct;29(5):488-92. doi: 10.1093/ejo/cjm038.
PubMed 17974538Moshkelgosha V, Mehrvarz S, Saki M, Golkari A. Computer-Based Oral Hygiene Instruction versus Verbal Method in Fixed Orthodontic Patients. J Dent Biomater. 2017 Mar;4(1):353-360.
PubMed 28959765Ousehal L, Lazrak L, Es-Said R, Hamdoune H, Elquars F, Khadija A. Evaluation of dental plaque control in patients wearing fixed orthodontic appliances: a clinical study. Int Orthod. 2011 Mar;9(1):140-55. doi: 10.1016/j.ortho.2010.12.013. Epub 2011 Feb 1. English, French.
PubMed 21277846Huang J, Yao Y, Jiang J, Li C. Effects of motivational methods on oral hygiene of orthodontic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Nov;97(47):e13182. doi: 10.1097/MD.0000000000013182.
PubMed 30461616Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003.
PubMed 16473715Kay E, Locker D. A systematic review of the effectiveness of health promotion aimed at improving oral health. Community Dent Health. 1998 Sep;15(3):132-44.
PubMed 10645682Rollnick S, Miller WR, Butler C. Motivational Interviewing in Health Care. Helping Patients Change Behavior. New York, NY, USA: Guilford Press; 2008
Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
PubMed 19364414Gao X, Lo EC, McGrath C, Ho SM. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial. Trials. 2015 Sep 18;16:416. doi: 10.1186/s13063-015-0946-0.
PubMed 26385340Miller WR, Rollnick S. Motivational interviewing: Helping people change. 3rd ed. New York: Guilford Press; 2013
Miller RW, Rollnick S. Motivational Interviewing: Preparing People for Change. New York: Guilford Press; 2002.
Miller WR. A small study of training in motivational interviewing: does one workshop change clinician and client behavior? Behav Cogn Psychother 2001;29:457-71.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing on Oral Hygiene Behavior in Patients With Fixed Orthodontic Appliances: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04871373
- Acronym / sponsor ID
- CEI2017-06
- Keywords
- Motivational interviewing, Oral hygiene, Fixed orthodontic appliances, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad IberoamericanaUniversity, hospital or other
- Collaborators
- Laboratorios Collado
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 4 May 2021 (actual)
- 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.
A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison with conventional oral hygiene instructions alone.
A computer-generated list of numbers created with Statistical Package for the Social Sciences (SPSS) V21.0 was used to random allocate participants into the experimental or the control group. Monthly oral hygiene instructions and a G.U.M. kit were given to the sample. Additionally, the experimental group received motivational interviewing sessions by a trained periodontist. Simplified Oral Hygiene Index, Gingival Index, Periodontal Probing Depth and Bleeding on Probing were recorded at baseline, three and six months after the beginning of the study. Repeated-measures analysis of variance and chi-squared test were conducted.
Detailed description
Sample calculation A power analysis was carried out to determine the number of subjects needed to achieve a Simplified Oral Hygiene Index (SOHI) significant interaction with the study groups when applying repeated measures ANOVA. The total number of completed subjects needed to achieve power of 0.90 with an alpha (α) of 0.05, an effect size (f) of at least .25 was determined to be 36; taking into consideration a possible 10% attrition rate, 45 subjects were recruited, consented and randomized to either the experimental or control group.
Due to the matter that repeated measures ANOVA treats each measurement as a separate variable, and it's preferable to use listwise deletion, if one measurement is missing, the whole case gets dropped. For this reason and therefore the incontrovertible fact that the trial suffers attrition, the sample for the three measurements was reduced to 32 subjects.
Randomization A simple randomization procedure was executed by the principal investigator to allocate the participants into one of the study groups. A computer-generated list of numbers was created using the software SPSS V21.0, with a 1:1.25 allocation ratio.
Two dentists enrolled and allocated the participants according to the order of arrival and following the list of random numbers. A coding system was used as a concealment mechanism, which consisted of colored labels attached to the participants' file. Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.
Study intervention An interviewer was in charge of providing oral hygiene instructions for both groups. All the participants received a G.U.M. kit with special orthodontic hygiene tools. Then, the patients of the experimental group received a motivational interviewing session.
Afterward, the clinical parameters were measured by another periodontist. Monthly follow-up appointments were scheduled for the orthodontic check-ups to deliver a new G.U.M. kit, to reinforce the OHI and MI, and to register the periodontal parameters. The important data for this research was the one recorded at baseline, three and six months after the intervention.
Statistical analysis Mean Simplify oral hygiene index (SOHI), gingival index (GI), periodontal probing depth (PPD), and bleeding on probing (BoP) scores were compared between groups across three-time points using repeated-measures mixed-model analysis of variance. Tests for equality of variances and sphericity to check for homoscedasticity were performed due to the problem of sample attrition. Nevertheless, it was not found any violation to these assumptions in any of the variables included in the analysis. SPSS software was used for all calculations (IBM SPSS 25th version). Due to the nominal level of measurement of the variable BoP, it was performed a chi-squared test for each three time points to check if there were any differences between the two experimental conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Orthodontic patients were recruited to be divided into a control group (that received oral hygiene instructions) and an experimental group (that received oral hygiene instructions and motivational interviewing sessions).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Motivational interviewing, Behavioral: Oral Hygiene InstructionsA trained periodontist delivered oral hygiene instructions and motivational interviewing sessions. All the participants received a G.U.M. kit with special orthodontic hygiene tools. |
| Control group | Active comparator | Behavioral: Oral Hygiene InstructionsA trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with 18-40 years old, systemically healthy, without active dental caries lesions or periodontal diseases, who were candidates for fixed orthodontic appliances.
Key exclusion criteria (2 listed)
- Smokers and pregnant patients.
- Participants were discarded if they decided voluntarily to abandon the study of the orthodontic treatment or if they didn't attend to the periodical check-ups.
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 |
|---|---|---|
| Motivational interviewingAlso: Motivational interviewA periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group. | Behavioural | Experimental group |
| Oral Hygiene InstructionsAlso: OHIA periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools. | Behavioural | Control group, Experimental group |
Primary outcome
Simplified Oral Hygiene Index
Time frame: Base line.
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Simplified Oral Hygiene Index
Time frame: 3rd month
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
Simplified Oral Hygiene Index
Time frame: 6th month
six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.
3 secondary outcomes
Gingival Index
Time frame: Base line, 3 and 6 months after the intervention.
Periodontal Probing Depth
Time frame: Base line, 3 and 6 months after the intervention.
Bleeding on Probing
Time frame: Base line, 3 and 6 months after the intervention.
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 4 May 2021.
- Background: PubMed 32110465Yavan MA, Kocahan S, Ozdemir S, Sokucu O. The Effects of Using Plaque-Disclosing Tablets on the Removal of Plaque and Gingival Status of Orthodontic Patients. Turk J Orthod. 2019 Dec 1;32(4):207-214. doi: 10.5152/TurkJOrthod.2019.18084. eCollection 2019 Dec.
- Background: PubMed 290273Alstad S, Zachrisson BU. Longitudinal study of periodontal condition associated with orthodontic treatment in adolescents. Am J Orthod. 1979 Sep;76(3):277-86. doi: 10.1016/0002-9416(79)90024-1. No abstract available.
- Background: PubMed 31581420Petrauskiene S, Wanczewska N, Slabsinskiene E, Zemgulyte G. Self-Reported Changes in Oral Hygiene Habits among Adolescents Receiving Orthodontic Treatment. Dent J (Basel). 2019 Oct 1;7(4):96. doi: 10.3390/dj7040096.
- Background: PubMed 17974538Arici S, Alkan A, Arici N. Comparison of different toothbrushing protocols in poor-toothbrushing orthodontic patients. Eur J Orthod. 2007 Oct;29(5):488-92. doi: 10.1093/ejo/cjm038.
- Background: PubMed 28959765Moshkelgosha V, Mehrvarz S, Saki M, Golkari A. Computer-Based Oral Hygiene Instruction versus Verbal Method in Fixed Orthodontic Patients. J Dent Biomater. 2017 Mar;4(1):353-360.
- Background: PubMed 21277846Ousehal L, Lazrak L, Es-Said R, Hamdoune H, Elquars F, Khadija A. Evaluation of dental plaque control in patients wearing fixed orthodontic appliances: a clinical study. Int Orthod. 2011 Mar;9(1):140-55. doi: 10.1016/j.ortho.2010.12.013. Epub 2011 Feb 1. English, French.
- Background: PubMed 30461616Huang J, Yao Y, Jiang J, Li C. Effects of motivational methods on oral hygiene of orthodontic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Nov;97(47):e13182. doi: 10.1097/MD.0000000000013182.
- Background: PubMed 16473715Skidmore KJ, Brook KJ, Thomson WM, Harding WJ. Factors influencing treatment time in orthodontic patients. Am J Orthod Dentofacial Orthop. 2006 Feb;129(2):230-8. doi: 10.1016/j.ajodo.2005.10.003.
- Background: PubMed 10645682Kay E, Locker D. A systematic review of the effectiveness of health promotion aimed at improving oral health. Community Dent Health. 1998 Sep;15(3):132-44.
- BackgroundRollnick S, Miller WR, Butler C. Motivational Interviewing in Health Care. Helping Patients Change Behavior. New York, NY, USA: Guilford Press; 2008
- Background: PubMed 19364414Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
- Background: PubMed 26385340Gao X, Lo EC, McGrath C, Ho SM. Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial. Trials. 2015 Sep 18;16:416. doi: 10.1186/s13063-015-0946-0.
- Individual participant dataSharing planned: No
Related trials for Motivational Interviewing
Not yet recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
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.
Henry A Adames, MsC principal investigator
Universidad Iberoamericana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing and Oral Hygiene Instructions in people with Motivational Interviewing and Oral Hygiene, run by Universidad Iberoamericana at 1 site in Dominican Republic.
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 1 inclusion and 2 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Simplified Oral Hygiene Index (time frame: Base line.). 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?
On the ClinicalTrials.gov record for NCT04871373, which also lists 43 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 4 May 2021.