Home » Trials » SLCTR/2026/028
Aligning Patient and Orthodontist Stop Thresholds in Finishing: A Pragmatic Dyadic Randomised Trial
-
SLCTR Registration Number
SLCTR/2026/028
Date of Registration
The date of last modification
Oct 20, 2026
Scientific Title of Trial
Aligning Patient and Orthodontist Stop Thresholds in Finishing: A Pragmatic Dyadic Randomised Trial
Public Title of Trial
Randomized controlled trial on effectivity of a structured finishing consultation compared to standard care in reducing patient-orthodontist discordance in treatment completion thresholds among orthodontics patients in the finishing phase
Disease or Health Condition(s) Studied
Orthodontic treatment
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1335-7436
Any other number(s) assigned to the trial and issuing authority
ODC-PG-NM-2025-234P3
What is the research question being addressed?
Does introducing a structured finishing consultation reduce discordance in completion thresholds compared to usual care in orthodontic patients during the finishing phase of treatment?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
This is a single-centre, parallel-group randomised trial at Oman Dental College, Al Maabilah, Seeb, Muscat, Oman, conducted during routine orthodontic finishing appointments. Sixty adult patients entering the finishing phase of active treatment will be allocated 1:1 (30 per arm). A computer-generated allocation sequence will be prepared in advance and concealed in sequentially numbered, sealed, opaque envelopes. After consent, enrolment and baseline assessment, the next envelope will be opened to assign the patient. Masking will not be used. Intervention arm: The patient and treating orthodontist will undertake a structured finishing consultation using a standardised guide developed for this study. It prompts discussion of residual discrepancies, the likely marginal benefit and burden of further treatment, patient priorities, and whether to continue finishing or proceed towards debonding. The guide is the intervention; it is not a previously validated questionnaire or outcome instrument. Control arm: The patient will receive the site’s usual orthodontic finishing consultation without the structured guide or mandated domain-by-domain discussion. Routine clinical assessment, further finishing adjustments and decisions about debonding will remain under the treating orthodontist’s usual care. Both arms will provide independent patient and clinician completion-threshold scores at baseline and the fixed 8–10-week follow-up.
Inclusion criteria
Patients - Aged 18 years or older; both males and females are eligible. - Receiving active orthodontic treatment at Oman Dental College. - Entering the finishing phase, with the major treatment objectives achieved and remaining work consisting primarily of detailing, settling and minor adjustments. - Estimated by the treating orthodontist to require approximately 12–16 weeks of finishing at baseline. - Able to complete the patient questionnaires independently. - Provide written informed consent.
Orthodontists - Have primary responsibility for the participating patient’s finishing and debonding decisions. - Agree to complete the clinician questionnaires at the required study time points.
Exclusion criteria
Patients - Remaining treatment is not comparable to routine finishing cases because substantial treatment objectives remain. - A treatment interruption of more than eight weeks is anticipated. - The treating orthodontist judges that the finishing phase is unlikely to proceed within the timeframe required by the study protocol.
Primary outcome(s)
|
1.
Change in patient–orthodontist discordance in treatment-completion thresholds. The patient and treating orthodontist independently record, on a 0–100 scale, the point at which each considers the orthodontic result sufficiently complete to end active treatment. Discordance is the absolute difference between their scores: |patient score ? orthodontist score|. The primary outcome is the follow-up discordance score minus the baseline discordance score. A negative change indicates improved agreement. |
[ Baseline: Before randomisation and the finishing consultation. Follow-up: 8–10 weeks after entry into the finishing phase. ] |
Secondary outcome(s)
Target number/sample size
60 (30 in the control group, 30 in the intervention group)
Countries of recruitment
Oman
Anticipated start date
2026-10-20
Anticipated end date
2027-02-19
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University
Regulatory approvals
Status
Approved
Date of Approval
2026-02-22
Approval number
ODC Research ODC-PG-NM-2025-234P3
Details of Ethics Review Committee
| Name: | Oman Dental College |
| Institutional Address: | Oman Dental College, Al Maabilah, Seeb, Muscat, Sultanate of Oman |
| Telephone: | +968 24665555 |
| Email: | info@odc.edu.om |
Contact person for Scientific Queries/Principal Investigator
Ali Abdul-Hamid
Resident Orthodontist
Oman Dental College, Al Maabilah, Seeb, Muscat, Sultanate of Oman
+968 97659017
ahamid@pg.odc.edu.om
Contact Person for Public Queries
Ali Abdul-Hamid
Resident Orthodontist
Oman Dental College, Al Maabilah, Seeb, Muscat, Sultanate of Oman
+968 97659017
ahamid@pg.odc.edu.om
Primary study sponsor/organization
Oman Dental College
Primary Sponsor
Oman Dental College, Al Maabilah, Seeb, Muscat, Sultanate of Oman
+968 24665555
Info@odc.edu.om
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results