Home » Trials » SLCTR/2026/028


Aligning Patient and Orthodontist Stop Thresholds in Finishing: A Pragmatic Dyadic Randomised Trial

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SLCTR Registration Number

SLCTR/2026/028


Date of Registration

20 Oct 2026

The date of last modification

Oct 20, 2026



Application Summary


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


Trial Details


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.

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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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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