Evaluation of the Perceived Experience of Patients Treated With Aligners With Two Different Timings

Condition(s) studied

Investigational drug(s) / intervention(s)

Biomax Nuvola aligners: All patients will be treated with Biomax Nuvola aligners built based on the individual patient's characteristics. The number of aligners and the number/type of attachments will be chosen on the basis of the individual malocclusions. In this group the attachments will be bonded at the beginning of first aligner. Two different questionnaires will be administered to the enrolled subjects: the italian version of the adapted OHIP-14 questionnaire, and a customized questionnaire. The questionnaires will be completed at different stages of orthodontic treatment, as following: 24 hours after the delivery of the first aligner - 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 clear aligner; 3 days after delivery of the third clear aligner; 7 days after delivery of the third clear aligner.

Biomax Nuvola aligners: All patients will be treated with Biomax Nuvola aligners built based on the individual atient's characteristics. The number of aligners and the number/type of attachments will be chosen on the basis of the individual malocclusions. In this group the attachments will be bonded at the beginning of third aligner, approximately one month after the start of orthodontic treatment. Two different questionnaires will be administered to the enrolled subjects: the italian version of the adapted OHIP-14 questionnaire, and a customized questionnaire. The questionnaires will be completed at different stages of orthodontic treatment, as following: 24 hours after the delivery of the first aligner - 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 clear aligner; 3 days after delivery of the third clear aligner; 7 days after delivery of the third clear aligner.

Study 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)

Eligibility

Primary outcome measure(s)

• Evaluation of a possible reduction in discomfort between the two protocols — 1 year
  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.

Trial sites (1)

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