Oral HygieneNCT03390452
Mobile Phone Messaging To Improve Oral Hygiene Among Primary School Children in Pakistan
A study testing Mobile Phone Messaging in people with Oral Hygiene and Dental Plaque Induced Gingivitis, run by Health Services Academy, Islamabad, Pakistan at 2 sites in Pakistan.
Trial summary
Oral health is an important component of general health and oral cavity acts as a mirror to the health of individuals and communities. Inadequate focus on primary prevention of oral diseases, poses a sizeable challenge for numerous countries, especially low and middle income countries. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Dental Plaque Induced Gingivitis
- What is being tested?
- Mobile Phone Messaging
- 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
- 362 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Sep 2018to 30 Oct 2019
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School children enrolled in primary schools (public and private) in Quetta city.
- Primary School children who are permanent residents of Quetta
Who cannot join
- Primary School children whose parents/caregivers do not own a mobile phone
- Primary School children having orthodontic or any other mouth appliance for example Braces etc.
- Primary School children who have been diagnosed for a systemic illness e.g. Blood disorders or, Diabetes
- Primary School children who are absent during the time of data collection
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Ashfaq Ahmed Khawajakhail
Quetta, Balochistan, 87300
Dental Section, Sandman Provincial Hospital Quetta
Quetta, Balochistan, 87300
About this study
Official title: Mobile Phone Messaging to Parents: To Improve Oral Hygiene Among Primary School Children In Quetta, Pakistan
Oral health is an important component of general health and oral cavity acts as a mirror to the health of individuals and communities. Inadequate focus on primary prevention of oral diseases, poses a sizeable challenge for numerous countries, especially low and middle income countries.
Mobile phone technology is relatively new and its successes in chronic disease is well documented but there is little evidence available in its use for improving oral health and dietary habits of children.
Read more
This will be a Pilot Randomized Control Trial (RCT) . It will be conducted in public and private sector schools of Quetta city, Pakistan. Study will comprise of intervention and a control arm. Duration of intervention is 6 months.
In the intervention group, study participants will be the parents. School teachers will send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health.
The primary school children in the control group will not receive any intervention
Read the detailed description
Oral health is a vital part of general health and oral cavity is considered as a mirror to the health of individuals and communities. Poor oral health has a great impact on general health and several oral conditions are found to be associated with heart and lung diseases, diabetes, low-birth-weight and premature births. Oral conditions also affect the quality of life through affecting speech, eating, education, facial appearance, confidence and social interaction.
Schools settings are important to reach children. School going age is considered as a receptive and influential phase in an individual's life during which lifelong health related behaviors, attitudes and beliefs are developed. Parents have great role in improving their children's oral health. They can influence their children oral health and behaviors and can provide a supportive environment to their children at home in terms of oral hygiene and diet and prevention of risk factors for oral diseases.
Mobile phone text messaging is a powerful tool for changing behaviors as these are common, available, low-cost, and quick.(30) Text messaging can be utilized in reducing the global burden of diseases by promoting healthy behaviors and supporting disease prevention
The main objective of this study is to assess the use of mobile phone (health) messages to Parents of public and private sector primary school children to improve their oral hygiene status
This study will be a Pilot Randomized Control Trial (RCT), comprising of two arms Intervention and Control arm.
In the intervention groups study participants will be the school teachers, parents and primary school children. School teachers will be provided messages (designed by Dental Public Health Professionals or adopted from other sources) through the researcher himself. The teachers will then form groups to send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health. Parents will receive mobile phone messages about oral hygiene and healthy dieting of their children by the teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. School Children will be evaluated on their oral hygiene through gingival bleeding and plaque scores at the start of intervention, after three months and at the end of intervention i.e six months.
The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at 3 months and at six month interval to compare for differences (if any) with intervention group.
The total duration of this study is two years (2017 to 2018) including the intervention which will be of six months duration.
After six months of start of intervention; both the intervention group and the control group will be assessed and evaluated on the primary outcome i.e. Oral hygiene measured through "Oral Hygiene Index" which is a standardized index for assessing oral hygiene and recommended by World health Organization.
- Conditions
- Oral Hygiene, Dental Plaque Induced Gingivitis
- Being tested
- Mobile Phone Messaging
- Keywords
- mHealth, Oral Health, Primary School Children, Mobile Phone Messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone MessagingBehavioural
Parents of primary school children will receive "Mobile Phone Messages" regarding their children's oral hygiene maintenance and their positive dietary habits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The parents will receive "Mobile phone messages" about oral hygiene and healthy dieting of their children through teachers.
The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months.
Oral hygiene of School children will be assessed before intervention, after 6 months interval Receives: Behavioral: Mobile Phone Messaging |
| Control | No intervention | The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at six month interval to compare for differences (if any) with intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Oral Hygiene Index Scores
Oral hygiene will be measured through "Simplified Oral Hygiene Index" (OHI-S). Each participant will undergo a dental examination in the school by a trained group of examiners (Qualified Dentists). The WHO recommended protocols for Dental examinations will be followed in assessing outcome measure.
Simplified Oral Hygiene Index (OHI-S) was developed by Greene and Vermillion in 1964. The OHI-S has two components, the Debris Index (DI) and the Calculus Index (CI). Each of these indexes is based on numerical determinations representing the amount of debris or calculus found on the pre-selected tooth surfaces. For each individual, the debris scores are totaled and divided by the number of surfaces scored. The average individual or group debris and calculus scores are combined to obtain the "Simplified Oral Hygiene Index".
The group baseline scores for both the arms will be compared with the post-intervention scores to observe the change (if any) to conclude the study results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Sep 2018
- Primary completion30 Apr 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Services Academy, Islamabad, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashfaq Ahmed Khawaja Khail, Health Services Academy, Islamabad, Pakistan
- Investigators
- Ashfaq A Khawajakhail, MPH, Principal investigator, Health services Academy, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390452
- Sponsor's protocol ID
- 2212-HSA/Ph.D-2015
- Status last verified
- Feb 2021
- First submitted
- 11 Aug 2016
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
PubMed 15015736Higgs ES, Goldberg AB, Labrique AB, Cook SH, Schmid C, Cole CF, Obregon RA. Understanding the role of mHealth and other media interventions for behavior change to enhance child survival and development in low- and middle-income countries: an evidence review. J Health Commun. 2014;19 Suppl 1(sup1):164-89. doi: 10.1080/10810730.2014.929763.
PubMed 25207452Kay 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 10645682Ben-Zeev D, Schueller SM, Begale M, Duffecy J, Kane JM, Mohr DC. Strategies for mHealth research: lessons from 3 mobile intervention studies. Adm Policy Ment Health. 2015 Mar;42(2):157-67. doi: 10.1007/s10488-014-0556-2.
PubMed 24824311Watt RG. Strategies and approaches in oral disease prevention and health promotion. Bull World Health Organ. 2005 Sep;83(9):711-8. Epub 2005 Sep 30.
PubMed 16211164Haleem A, Siddiqui MI, Khan AA. School-based strategies for oral health education of adolescents--a cluster randomized controlled trial. BMC Oral Health. 2012 Dec 18;12:54. doi: 10.1186/1472-6831-12-54.
PubMed 23249443Saied-Moallemi Z, Virtanen JI, Vehkalahti MM, Tehranchi A, Murtomaa H. School-based intervention to promote preadolescents' gingival health: a community trial. Community Dent Oral Epidemiol. 2009 Dec;37(6):518-26. doi: 10.1111/j.1600-0528.2009.00491.x. Epub 2009 Aug 20.
PubMed 19694774da Costa TM, Barbosa BJ, Gomes e Costa DA, Sigulem D, de Fatima Marin H, Filho AC, Pisa IT. Results of a randomized controlled trial to assess the effects of a mobile SMS-based intervention on treatment adherence in HIV/AIDS-infected Brazilian women and impressions and satisfaction with respect to incoming messages. Int J Med Inform. 2012 Apr;81(4):257-69. doi: 10.1016/j.ijmedinf.2011.10.002. Epub 2012 Jan 31.
PubMed 22296762Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014 Sep;70(9):1932-1953. doi: 10.1111/jan.12400. Epub 2014 Apr 1.
PubMed 24689978Nyandindi U, Palin-Palokas T, Milen A, Robison V, Kombe N, Mwakasagule S. Participation, willingness and abilities of school-teachers in oral health education in Tanzania. Community Dent Health. 1994 Jun;11(2):101-4.
PubMed 8044706de Silva-Sanigorski A, Ashbolt R, Green J, Calache H, Keith B, Riggs E, Waters E. Parental self-efficacy and oral health-related knowledge are associated with parent and child oral health behaviors and self-reported oral health status. Community Dent Oral Epidemiol. 2013 Aug;41(4):345-52. doi: 10.1111/cdoe.12019. Epub 2012 Nov 17.
PubMed 23157162Sharma R, Hebbal M, Ankola AV, Murugabupathy V. Mobile-phone text messaging (SMS) for providing oral health education to mothers of preschool children in Belgaum City. J Telemed Telecare. 2011;17(8):432-6. doi: 10.1258/jtt.2011.110416. Epub 2011 Oct 24.
PubMed 22025742Hall AK, Cole-Lewis H, Bernhardt JM. Mobile text messaging for health: a systematic review of reviews. Annu Rev Public Health. 2015 Mar 18;36:393-415. doi: 10.1146/annurev-publhealth-031914-122855.
PubMed 25785892Castilho AR, Mialhe FL, Barbosa Tde S, Puppin-Rontani RM. Influence of family environment on children's oral health: a systematic review. J Pediatr (Rio J). 2013 Mar-Apr;89(2):116-23. doi: 10.1016/j.jped.2013.03.014.
PubMed 23642420Folayan MO, Kolawole KA, Oyedele T, Chukwumah NM, Onyejaka N, Agbaje H, Oziegbe EO, Oshomoji OV. Association between knowledge of caries preventive practices, preventive oral health habits of parents and children and caries experience in children resident in sub-urban Nigeria. BMC Oral Health. 2014 Dec 16;14:156. doi: 10.1186/1472-6831-14-156.
PubMed 25516332
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Messaging to Parents: To Improve Oral Hygiene Among Primary School Children In Quetta, Pakistan
- ClinicalTrials.gov ID
- NCT03390452
- Acronym / sponsor ID
- 2212-HSA/Ph.D-2015
- Conditions
- Oral Hygiene, Dental Plaque Induced Gingivitis
- Keywords
- mHealth, Oral Health, Primary School Children, Mobile Phone Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Health Services Academy, Islamabad, PakistanUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 4 Jan 2018 (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.
Oral health is an important component of general health and oral cavity acts as a mirror to the health of individuals and communities. Inadequate focus on primary prevention of oral diseases, poses a sizeable challenge for numerous countries, especially low and middle income countries.
Mobile phone technology is relatively new and its successes in chronic disease is well documented but there is little evidence available in its use for improving oral health and dietary habits of children.
This will be a Pilot Randomized Control Trial (RCT) . It will be conducted in public and private sector schools of Quetta city, Pakistan. Study will comprise of intervention and a control arm. Duration of intervention is 6 months.
In the intervention group, study participants will be the parents. School teachers will send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health.
The primary school children in the control group will not receive any intervention
Detailed description
Oral health is a vital part of general health and oral cavity is considered as a mirror to the health of individuals and communities. Poor oral health has a great impact on general health and several oral conditions are found to be associated with heart and lung diseases, diabetes, low-birth-weight and premature births. Oral conditions also affect the quality of life through affecting speech, eating, education, facial appearance, confidence and social interaction.
Schools settings are important to reach children. School going age is considered as a receptive and influential phase in an individual's life during which lifelong health related behaviors, attitudes and beliefs are developed. Parents have great role in improving their children's oral health. They can influence their children oral health and behaviors and can provide a supportive environment to their children at home in terms of oral hygiene and diet and prevention of risk factors for oral diseases.
Mobile phone text messaging is a powerful tool for changing behaviors as these are common, available, low-cost, and quick.(30) Text messaging can be utilized in reducing the global burden of diseases by promoting healthy behaviors and supporting disease prevention
The main objective of this study is to assess the use of mobile phone (health) messages to Parents of public and private sector primary school children to improve their oral hygiene status
This study will be a Pilot Randomized Control Trial (RCT), comprising of two arms Intervention and Control arm.
In the intervention groups study participants will be the school teachers, parents and primary school children. School teachers will be provided messages (designed by Dental Public Health Professionals or adopted from other sources) through the researcher himself. The teachers will then form groups to send oral health education and reminder messages on frequent intervals to educate children's parents on oral hygiene and reinforce their behaviors to improve their child oral health. Parents will receive mobile phone messages about oral hygiene and healthy dieting of their children by the teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. School Children will be evaluated on their oral hygiene through gingival bleeding and plaque scores at the start of intervention, after three months and at the end of intervention i.e six months.
The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at 3 months and at six month interval to compare for differences (if any) with intervention group.
The total duration of this study is two years (2017 to 2018) including the intervention which will be of six months duration.
After six months of start of intervention; both the intervention group and the control group will be assessed and evaluated on the primary outcome i.e. Oral hygiene measured through "Oral Hygiene Index" which is a standardized index for assessing oral hygiene and recommended by World health Organization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mobile Phone MessagingThe parents will receive "Mobile phone messages" about oral hygiene and healthy dieting of their children through teachers. The message format will be text and images, depending upon the education/ literacy level of the parents. Parents will be reminded and information reinforced, at frequent intervals for a period of six months. Oral hygiene of School children will be assessed before intervention, after 6 months interval |
| Control | No intervention | –The primary school children in the control group will not receive any intervention via their parents or teachers (in-active controls) but will be observed on selected outcome measures for baseline data, then at six month interval to compare for differences (if any) with intervention group. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School children enrolled in primary schools (public and private) in Quetta city.
- Primary School children who are permanent residents of Quetta
Key exclusion criteria (4 listed)
- Primary School children whose parents/caregivers do not own a mobile phone
- Primary School children having orthodontic or any other mouth appliance for example Braces etc.
- Primary School children who have been diagnosed for a systemic illness e.g. Blood disorders or, Diabetes
- Primary School children who are absent during the time of data collection
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 |
|---|---|---|
| Mobile Phone MessagingParents of primary school children will receive "Mobile Phone Messages" regarding their children's oral hygiene maintenance and their positive dietary habits. | Behavioural | Intervention |
Primary outcome
Change in the Oral Hygiene Index Scores
Time frame: 6 months
Oral hygiene will be measured through "Simplified Oral Hygiene Index" (OHI-S). Each participant will undergo a dental examination in the school by a trained group of examiners (Qualified Dentists). The WHO recommended protocols for Dental examinations will be followed in assessing outcome measure. Simplified Oral Hygiene Index (OHI-S) was developed by Greene and Vermillion in 1964. The OHI-S has two components, the Debris Index (DI) and the Calculus Index (CI). Each of these indexes is based on numerical determinations representing the amount of debris or calculus found on the pre-selected tooth surfaces. For each individual, the debris scores are totaled and divided by the number of surfaces scored. The average individual or group debris and calculus scores are combined to obtain the "Simplified Oral Hygiene Index". The group baseline scores for both the arms will be compared with the post-intervention scores to observe the change (if any) to conclude the study results
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 11 Feb 2021.
- Background: PubMed 15015736Petersen PE. The World Oral Health Report 2003: continuous improvement of oral health in the 21st century--the approach of the WHO Global Oral Health Programme. Community Dent Oral Epidemiol. 2003 Dec;31 Suppl 1:3-23. doi: 10.1046/j..2003.com122.x.
- Background: PubMed 25207452Higgs ES, Goldberg AB, Labrique AB, Cook SH, Schmid C, Cole CF, Obregon RA. Understanding the role of mHealth and other media interventions for behavior change to enhance child survival and development in low- and middle-income countries: an evidence review. J Health Commun. 2014;19 Suppl 1(sup1):164-89. doi: 10.1080/10810730.2014.929763.
- 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.
- Background: PubMed 24824311Ben-Zeev D, Schueller SM, Begale M, Duffecy J, Kane JM, Mohr DC. Strategies for mHealth research: lessons from 3 mobile intervention studies. Adm Policy Ment Health. 2015 Mar;42(2):157-67. doi: 10.1007/s10488-014-0556-2.
- Background: PubMed 16211164Watt RG. Strategies and approaches in oral disease prevention and health promotion. Bull World Health Organ. 2005 Sep;83(9):711-8. Epub 2005 Sep 30.
- Background: PubMed 23249443Haleem A, Siddiqui MI, Khan AA. School-based strategies for oral health education of adolescents--a cluster randomized controlled trial. BMC Oral Health. 2012 Dec 18;12:54. doi: 10.1186/1472-6831-12-54.
- Background: PubMed 19694774Saied-Moallemi Z, Virtanen JI, Vehkalahti MM, Tehranchi A, Murtomaa H. School-based intervention to promote preadolescents' gingival health: a community trial. Community Dent Oral Epidemiol. 2009 Dec;37(6):518-26. doi: 10.1111/j.1600-0528.2009.00491.x. Epub 2009 Aug 20.
- Background: PubMed 22296762da Costa TM, Barbosa BJ, Gomes e Costa DA, Sigulem D, de Fatima Marin H, Filho AC, Pisa IT. Results of a randomized controlled trial to assess the effects of a mobile SMS-based intervention on treatment adherence in HIV/AIDS-infected Brazilian women and impressions and satisfaction with respect to incoming messages. Int J Med Inform. 2012 Apr;81(4):257-69. doi: 10.1016/j.ijmedinf.2011.10.002. Epub 2012 Jan 31.
- Background: PubMed 24689978Park LG, Howie-Esquivel J, Dracup K. A quantitative systematic review of the efficacy of mobile phone interventions to improve medication adherence. J Adv Nurs. 2014 Sep;70(9):1932-1953. doi: 10.1111/jan.12400. Epub 2014 Apr 1.
- Background: PubMed 8044706Nyandindi U, Palin-Palokas T, Milen A, Robison V, Kombe N, Mwakasagule S. Participation, willingness and abilities of school-teachers in oral health education in Tanzania. Community Dent Health. 1994 Jun;11(2):101-4.
- Background: PubMed 23157162de Silva-Sanigorski A, Ashbolt R, Green J, Calache H, Keith B, Riggs E, Waters E. Parental self-efficacy and oral health-related knowledge are associated with parent and child oral health behaviors and self-reported oral health status. Community Dent Oral Epidemiol. 2013 Aug;41(4):345-52. doi: 10.1111/cdoe.12019. Epub 2012 Nov 17.
- Background: PubMed 22025742Sharma R, Hebbal M, Ankola AV, Murugabupathy V. Mobile-phone text messaging (SMS) for providing oral health education to mothers of preschool children in Belgaum City. J Telemed Telecare. 2011;17(8):432-6. doi: 10.1258/jtt.2011.110416. Epub 2011 Oct 24.
- Individual participant dataSharing planned: Undecided
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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.
Ashfaq A Khawajakhail, MPH principal investigator
Health services Academy, Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone Messaging in people with Oral Hygiene and Dental Plaque Induced Gingivitis, run by Health Services Academy, Islamabad, Pakistan at 2 sites in Pakistan.
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 2 inclusion and 4 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Change in the Oral Hygiene Index Scores (time frame: 6 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 NCT03390452, which also lists 15 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 11 Feb 2021.