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

NCT06536335 | Recruiting

• 1 other identifier: 6636
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Malocclusion

Keywords

Attachment; Discomfort; Malocclusion; Questionnaires

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Different timing of onset and disappearance of pain

  1 year

• Impact on patients' quality of life

  1 year

Study Arms (2)

Conventional protocol

ACTIVE COMPARATOR

A group of patients a group of patients to whom attachments will be bonded at the beginning of the first aligner.

Device: Biomax Nuvola aligners

Delayed protocol

EXPERIMENTAL

A group of patients to whom attachments will be bonded at the beginning of the third aligner, approximately one month after the start of orthodontic treatment.

Device: Biomax Nuvola aligners

Interventions

Biomax Nuvola aligners DEVICE

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.

Conventional protocol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years;
• Class I malocclusion
• Non-extractive treatment;
• No missing teeth (third molars excluded);
• Good oral and general health.
• Signature of written informed consent to participate in the study

You may not qualify if:

• Patients with tooth-related pain (presence of dental and/or periodontal abscesses and presence of gingivitis)
• Presence of semi-included elements;
• Patients taking bisphosphonates or other anti-resorptive drugs;
• Patients with conditions involving chronic pain and/or on chronic therapy with antifiammatories/opiods or other drugs that may act on pain perception;
• Patients with temporomandibular disorders;
• Patients with conditions that may impair the ability to objectively report any sensations of discomfort or pain (e.g., mental retardation, dementia);
• Refusal to sign the written informed consent to participate in the study

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC odontoiatria

Roma, 00168, Italy

RECRUITING

Related Publications (12)

• Weir T. Clear aligners in orthodontic treatment. Aust Dent J. 2017 Mar;62 Suppl 1:58-62. doi: 10.1111/adj.12480.

  PMID: 28297094 BACKGROUND

• Bergius M, Kiliaridis S, Berggren U. Pain in orthodontics. A review and discussion of the literature. J Orofac Orthop. 2000;61(2):125-37. doi: 10.1007/BF01300354. English, German.

  PMID: 10783564 BACKGROUND

• Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure. Eur J Oral Sci. 2002 Apr;110(2):92-8. doi: 10.1034/j.1600-0722.2002.11193.x.

  PMID: 12013568 BACKGROUND

• Rakhshan H, Rakhshan V. Pain and discomfort perceived during the initial stage of active fixed orthodontic treatment. Saudi Dent J. 2015 Apr;27(2):81-7. doi: 10.1016/j.sdentj.2014.11.002. Epub 2015 Jan 27.

  PMID: 26082574 BACKGROUND

• Lew KK. Attitudes and perceptions of adults towards orthodontic treatment in an Asian community. Community Dent Oral Epidemiol. 1993 Feb;21(1):31-5. doi: 10.1111/j.1600-0528.1993.tb00715.x.

  PMID: 8432102 BACKGROUND

• Antonio-Zancajo L, Montero J, Albaladejo A, Oteo-Calatayud MD, Alvarado-Lorenzo A. Pain and Oral-Health-Related Quality of Life in Orthodontic Patients During Initial Therapy with Conventional, Low-Friction, and Lingual Brackets and Aligners (Invisalign): A Prospective Clinical Study. J Clin Med. 2020 Jul 3;9(7):2088. doi: 10.3390/jcm9072088.

  PMID: 32635196 BACKGROUND

• Tamer I, Oztas E, Marsan G. Orthodontic Treatment with Clear Aligners and The Scientific Reality Behind Their Marketing: A Literature Review. Turk J Orthod. 2019 Dec 1;32(4):241-246. doi: 10.5152/TurkJOrthod.2019.18083. eCollection 2019 Dec.

  PMID: 32110470 BACKGROUND

• White DW, Julien KC, Jacob H, Campbell PM, Buschang PH. Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial. Angle Orthod. 2017 Nov;87(6):801-808. doi: 10.2319/091416-687.1. Epub 2017 Jul 28.

  PMID: 28753032 BACKGROUND

• Cardoso PC, Espinosa DG, Mecenas P, Flores-Mir C, Normando D. Pain level between clear aligners and fixed appliances: a systematic review. Prog Orthod. 2020 Jan 20;21(1):3. doi: 10.1186/s40510-019-0303-z.

  PMID: 31956934 BACKGROUND

• Almasoud NN. Pain perception among patients treated with passive self-ligating fixed appliances and Invisalign(R) aligners during the first week of orthodontic treatment. Korean J Orthod. 2018 Sep;48(5):326-332. doi: 10.4041/kjod.2018.48.5.326. Epub 2018 Aug 8.

  PMID: 30206531 BACKGROUND

• Franchignoni M, Giordano A, Brigatti E, Migliario M, Levrini L, Ferriero G. [Psychometric properties of the Italian version of the reduced form of the Oral Health Impact Profile (OHIP-14)]. G Ital Med Lav Ergon. 2010 Jul-Sep;32(3 Suppl B):B71-8. Italian.

  PMID: 21302527 BACKGROUND

• Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.

  PMID: 29794282 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Massimo Cordaro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Cordaro

CONTACT

+063015; massimo.cordaro@policlinicogemelli.it

Edoardo Staderini

CONTACT

+393334154329; edoardo.staderini@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator does not know to which group the patient who sent in the questionnaire belongs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized controlled clinical trial

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-07

Locations

IT (1)