Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols (ATTACH-1)

July 17, 2024 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • UOC Odontoiatria Generale e Ortodonzia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CP- Conventional protocol
A group of patients a group of patients to whom attachments will be bonded at the beginning of the first aligner.
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.
Experimental: DP - delayed protocol
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaires used and how scores were assessed
Time Frame: 37 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 22, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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