Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols

Malocclusion Clinical Trial

— ATTACH-1  

Official title:

Evaluation of Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols. Single-blind Randomised Controlled Pilot Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218641
• Other study ID #: 5699
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: December 22, 2024

Study information

• Verified date: January 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Edoardo Staderini, Dentistry
• Phone: +39 3334154329
• Email: edoardo.staderini[@]unicatt.it
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 22, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 40 years;

• Class I and II 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• CP - conventional protocol
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.
• DP - delayed protocol
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 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.

Locations

Country	Name	City	State
Italy	UOC Odontoiatria Generale e Ortodonzia	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaires used and how scores were assessed	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.	37 days