Patient SatisfactionNCT04928768
Factors Influencing Patient Satisfaction in an Egyptian Sample After Orthodontic Treatment of Different Malocclusions
An observational study of Patient Satisfaction, run by Cairo University at 1 site in Egypt.
Trial summary
Previously, patient satisfaction with orthodontic treatment has been reported at a broad range of 34% to 95% but these values mostly represent satisfaction for tooth alignment or simple satisfaction with treatment results. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Questionnaire
- How many people
- 197 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 Jun 2022
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: male and female patients above 16 years with different malocclusion who recieved and completed their fixed orthodontic treatment
Who may be able to join
- Male and female patients with different malocclusions who received and completed their fixed orthodontic treatment.
- Age: 16 years old or above.
- Patients who have completed their orthodontic treatment between November 2020 and November 2021.
Who cannot join
- Patients who refuse to participate in the study.
- Patients below 16 years old.
- Illiterate patients.
- Patients who finished their treatment before November 2020 and after November 2021
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry - Cairo university
Cairo, 33333
Amira Aboelnaga, 00201000505688, amira_aboalnaga@dentistry.cu.edu.eg
Hakam, 00201020199099, yomna.elfaisal@dentistry.cu.edu.eg
About this study
Official title: Factors Influencing Patient Satisfaction in an Egyptian Sample After Orthodontic Treatment of Different Malocclusions. An Observational Cross Sectional Study
Previously, patient satisfaction with orthodontic treatment has been reported at a broad range of 34% to 95% but these values mostly represent satisfaction for tooth alignment or simple satisfaction with treatment results. In keeping with the increased focus on patient satisfaction, many other factors were put into consideration in our study which contributes to the level of total satisfaction as host factors, concerns regarding the treatment, treatment motivation and discomfort during or after treatment. There are also a lack of studies conducted for orthodontic treatment satisfaction using previously validated questionnaires as well as correlation between patient's treatment satisfaction and ABO grading hasn't been sufficiently discussed in the literature, this study aims to address that gap. It would be also beneficial to investigate the frequency of different malocclusions presented in a sample of postorthodontic patients as it will give an insight about the distribution of the different malocclusion treated within the clinic and the degree of success in treating such malocclusions.
Read the detailed description
Research Procedure in brief:
The following will be done for each participant:
Collection of patients telephone numbers:
Through the orthodontic department patient's database ensuring complete confidentiality. Telephoning the patients for follow ups after orthodontic treatment and asking them to fill in a questionnaire during their visit for explaining our aim for the study.
Personal data chart:
Including name, age, date of birth, mobile number and address. Examination of pretreatment records of the patients included in the sample to detect the type of malocclusion presented initially.
Orthodontic treatment satisfaction questionnaire:
The questionnaire is reviewed by faculty experts to determine whether the items in the questionnaire truly represent the items to be measured.
The translated questionnaire's face validation is led by the expert faculty members who are specialists in both English and Arabic guaranteeing clarity, intelligibility and comprehensiveness of items. This is significant in light of the fact that while performing any questionnaire in another setting, not all of the items may be compatible to Egyptian culture and lifestyles. In addition, a portion of items may not be applicable to specific age groups.
ABO Grading System Study models will be selected from the orthodontic department database. The post-treatment models will be assessed using the MGS of the American Board of Orthodontics.
- Conditions
- Patient Satisfaction
- Being tested
- Questionnaire
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A validated questionnaire (five-point Likert scale) through 10 items developed by Lee et al 2018 is employed to measure the level of orthodontic treatment satisfaction in 10 items; overall satisfaction, tooth alignment, facial appearance, eating and chewing, confident smile and self-image, retention state, treatment duration, treatment costs, intention to recommend, and relief of previous concerns. Total satisfaction is calculated by averaging the Likert scores from the 10 items
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall level of Orthodontic treatment satisfaction
unit of measurement: Likert Score form 1 to 5 (Qualitative- Ordinal)
Measured: 1 year
Secondary outcomes (1)
ABO grading of the finished cases
unit of measurement : ABO grading in points (Quantitative measures)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Nov 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Abdallah Elfaisal AbdelHakam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928768
- Sponsor's protocol ID
- 39012
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 16 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keles F, Bos A. Satisfaction with orthodontic treatment. Angle Orthod. 2013 May;83(3):507-11. doi: 10.2319/092112-754.1. Epub 2012 Nov 26.
PubMed 23181757Lee R, Hwang S, Lim H, Cha JY, Kim KH, Chung CJ. Treatment satisfaction and its influencing factors among adult orthodontic patients. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):808-817. doi: 10.1016/j.ajodo.2017.09.015.
PubMed 29853238Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
PubMed 17319767Al-Omiri MK, Abu Alhaija ES. Factors affecting patient satisfaction after orthodontic treatment. Angle Orthod. 2006 May;76(3):422-31. doi: 10.1043/0003-3219(2006)076[0422:FAPSAO]2.0.CO;2.
PubMed 16637722Elfaisal YA, Aboalnaga AA, Salah Fayed MM. Patient satisfaction following orthodontic treatment and its association with ABO Model Grading System: a cross-sectional study. BMC Oral Health. 2026 Mar 23;26(1):621. doi: 10.1186/s12903-026-07980-w.
PubMed 41866471
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Patient Satisfaction in an Egyptian Sample After Orthodontic Treatment of Different Malocclusions. An Observational Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04928768
- Acronym / sponsor ID
- 39012
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 16 Jun 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.
Previously, patient satisfaction with orthodontic treatment has been reported at a broad range of 34% to 95% but these values mostly represent satisfaction for tooth alignment or simple satisfaction with treatment results. In keeping with the increased focus on patient satisfaction, many other factors were put into consideration in our study which contributes to the level of total satisfaction as host factors, concerns regarding the treatment, treatment motivation and discomfort during or after treatment. There are also a lack of studies conducted for orthodontic treatment satisfaction using previously validated questionnaires as well as correlation between patient's treatment satisfaction and ABO grading hasn't been sufficiently discussed in the literature, this study aims to address that gap. It would be also beneficial to investigate the frequency of different malocclusions presented in a sample of postorthodontic patients as it will give an insight about the distribution of the different malocclusion treated within the clinic and the degree of success in treating such malocclusions.
Detailed description
Research Procedure in brief:
The following will be done for each participant:
Collection of patients telephone numbers:
Through the orthodontic department patient's database ensuring complete confidentiality. Telephoning the patients for follow ups after orthodontic treatment and asking them to fill in a questionnaire during their visit for explaining our aim for the study.
Personal data chart:
Including name, age, date of birth, mobile number and address. Examination of pretreatment records of the patients included in the sample to detect the type of malocclusion presented initially.
Orthodontic treatment satisfaction questionnaire:
The questionnaire is reviewed by faculty experts to determine whether the items in the questionnaire truly represent the items to be measured.
The translated questionnaire's face validation is led by the expert faculty members who are specialists in both English and Arabic guaranteeing clarity, intelligibility and comprehensiveness of items. This is significant in light of the fact that while performing any questionnaire in another setting, not all of the items may be compatible to Egyptian culture and lifestyles. In addition, a portion of items may not be applicable to specific age groups.
ABO Grading System Study models will be selected from the orthodontic department database. The post-treatment models will be assessed using the MGS of the American Board of Orthodontics.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- male and female patients above 16 years with different malocclusion who recieved and completed their fixed orthodontic treatment
Key inclusion criteria (3 listed)
- Male and female patients with different malocclusions who received and completed their fixed orthodontic treatment.
- Age: 16 years old or above.
- Patients who have completed their orthodontic treatment between November 2020 and November 2021.
Key exclusion criteria (4 listed)
- Patients who refuse to participate in the study.
- Patients below 16 years old.
- Illiterate patients.
- Patients who finished their treatment before November 2020 and after November 2021
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 |
|---|---|---|
| QuestionnaireA validated questionnaire (five-point Likert scale) through 10 items developed by Lee et al 2018 is employed to measure the level of orthodontic treatment satisfaction in 10 items; overall satisfaction, tooth alignment, facial appearance, eating and chewing, confident smile and self-image, retention state, treatment duration, treatment costs, intention to recommend, and relief of previous concerns. Total satisfaction is calculated by averaging the Likert scores from the 10 items | Other | – |
Primary outcome
Overall level of Orthodontic treatment satisfaction
Time frame: 1 year
unit of measurement: Likert Score form 1 to 5 (Qualitative- Ordinal)
1 secondary outcome
ABO grading of the finished cases
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 23181757Keles F, Bos A. Satisfaction with orthodontic treatment. Angle Orthod. 2013 May;83(3):507-11. doi: 10.2319/092112-754.1. Epub 2012 Nov 26.
- Background: PubMed 29853238Lee R, Hwang S, Lim H, Cha JY, Kim KH, Chung CJ. Treatment satisfaction and its influencing factors among adult orthodontic patients. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):808-817. doi: 10.1016/j.ajodo.2017.09.015.
- Background: PubMed 17319767Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
- Results publication: PubMed 16637722Al-Omiri MK, Abu Alhaija ES. Factors affecting patient satisfaction after orthodontic treatment. Angle Orthod. 2006 May;76(3):422-31. doi: 10.1043/0003-3219(2006)076[0422:FAPSAO]2.0.CO;2.
- Derived from this study: PubMed 41866471Elfaisal YA, Aboalnaga AA, Salah Fayed MM. Patient satisfaction following orthodontic treatment and its association with ABO Model Grading System: a cross-sectional study. BMC Oral Health. 2026 Mar 23;26(1):621. doi: 10.1186/s12903-026-07980-w.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, run by Cairo University at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 16 Jun 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Aboulnaga (00201000505688, amira_aboalnaga@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall level of Orthodontic treatment satisfaction (time frame: 1 year). 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 NCT04928768, which also lists 5 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 16 Jun 2021.