Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

The study was approved by the Institutional Review board of the Catholic University of the Sacred Hearth, Rome, Italy (prot. n. 17048/23). All adult patients with class I and II malocclusion referred to the Fondazione Policlinico Universitario Agostino Gemelli will be consecutively enrolled for this study. 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. Patients will be randomly allocated in two different groups: the study group includes patients following the delayed protocol (DP), while the control group is composed of patients' following the conventional protocol (CP). The aligner will be changed every 15 days, so the attachment placement in the DP will be performed around 30 days from the beginning of the clear aligner treatment. The modified OHIP Italian version has 20 questions categorized into 7 sections, concerning the limitation generated by deterioration of oral health in relation to clear aligners: functional, pain, psychological discomfort, physical or psychological or social disability, and handicap. The answers range from 0 (never) to 4 (very often). Possible categories are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). Low scores indicate better self-perception of quality of life. The customised questionnaire has 9 questions, concerning the limitation generated by discomfort caused by attachments. For 8 questions, the answers range from 0 (never) to 4 (very often). Possible categories are: never (0), rarely (1), sometimes (2), habitually (3), and very often (4). Low scores indicate better self-perception of quality of life. For the last question the answer is based on NRS scale, in fact it ranges from 0 to 10. Lower score indicates less pain perceived by the patient. The questionnaires will be filled out at different phases of orthodontic treatment, specifically: at the delivery of the first aligner, after 3 and 7 days; at the delivery of the third aligner, after 3 and 7 days. The survey scheduling is arranged according to White, who stated that the patients' perception of pain and discomfort occurred within 7 days after the beginning of the orthodontic treatment; then, patients' quality of life tends to return to a baseline condition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06218641
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Edoardo Staderini, Dentistry
Phone +39 3334154329
Email edoardo.staderini@unicatt.it
Status Recruiting
Phase N/A
Start date October 10, 2023
Completion date December 22, 2024

See also
  Status Clinical Trial Phase
Completed NCT02914431 - Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery N/A
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Not yet recruiting NCT03794726 - Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery N/A
Not yet recruiting NCT03513003 - The Use of a Pacifier to Correct Malocclusions in Young Children N/A
Completed NCT02603289 - One Week Aligner Evaluation
Terminated NCT01210547 - Three-dimensional Assessment of Craniofacial Structures N/A
Completed NCT01463839 - Sleep Disorder and Oral Habits in Children N/A
Recruiting NCT04946201 - Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Recruiting NCT04117360 - Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
Active, not recruiting NCT06291129 - Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents N/A
Recruiting NCT05684510 - Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy N/A
Completed NCT02659813 - Orthodontic Archwire Effectiveness Trial N/A
Completed NCT02427763 - Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device Phase 0
Completed NCT02267811 - The Effect of OrthoPulseā„¢ on the Rate of Orthodontic Tooth Movement N/A
Completed NCT01962012 - Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners Phase 4
Completed NCT03405961 - A Comparison of Conventional Versus Digital PAR (Peer Assessment Rating) Scores Using an Intraoral Scanner
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Completed NCT05711160 - Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
Recruiting NCT06140043 - Augmented Reality for Orthognatic Surgery Patient Education Phase 2/Phase 3
Recruiting NCT05573308 - Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms N/A