Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings
NCT Number: NCT06536335
Acronym: ALLIN-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Malocclusion
Interventions: DEVICE: Biomax Nuvola aligners|DEVICE: Biomax Nuvola aligners
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-11-30
Locations: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria, Roma, 00168, Italy

Summary:
The primary aim of the study is to compare the perception of pain and discomfort with two different protocols of attachments' placement during clear aligner therapy: the conventional protocol (CP), when attachments' placement is performed are placed at the delivery of the first aligner; the delayed protocol (DP), when the attachments' placement is performed at the delivery of the third aligner. The rationale of this study is to evaluate whether dividing the two phases most associated with the onset of pain and discomfort, namely the initiation of aligner therapy and the placement of attachments, can improve patients' quality of life during clear aligner treatment. Patients' discomfort will be evaluated with a questionnaire adapted by OHIP-14 (Oral Health Impact Profile 14)

Primary Outcome Measures: Evaluation of a possible reduction in discomfort between the two protocols, The primary objective of the study is to evaluate whether splitting the two phases most associated with the onset of pain and discomfort,i.e. the initiation of aligner therapy and the placement of attachments,can reduce these sensations and, consequently,improve adherence to treatment.Specifically,the level of pain symptomatology perceived by the patient will be assessed using the OHIP-14 scale.

The OHIP version has 14 questions,concerning the limitation generated by oral health impairment:functional limitation, pain, psychological discomfort, physical disability, psychological disability,social disability, and disability. The possible answers are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). The score is given by the sum of the values,from a minimum of 0 points to a maximum of 56 points., 1 year
Secondary Outcome Measures: Different timing of onset and disappearance of pain, Evaluation of whether the two protocols are associated with different timing of onset and disappearance of pain. In particular, this issue will be evaluated using a questionnaire developed for the study, with questions concerning the presence of discomfort due to aligner treatment and resin composite attachment. This questionnaire has 8 questions and the possible answers are: never(0), rarely(1), sometimes(2), habitually(3), and very often(4). The score is given by the sum of the values from a minimum of 0 points to a maximum of 32.This questionnaire will be sent with different timing, specifically:

* 24 hours after the start of orthodontic treatment;
* 3 days after the start of orthodontic treatment;
* 7 days after the start of orthodontic treatment;
* 24 hours after delivery of the third aligner;
* 3 days after delivery of the third aligner;
* 7 days after delivery of the third aligner., 1 year|Impact on patients' quality of life, Evaluate if the two protocols impact patients' quality of life differently. Specifically, the extent of pain symptomatology perceived by the patient will be assessed by the masked operator using the NRS scale (score 0-10, the lower it is, the less pain is perceived by the patient)., 1 year