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Pain and Discomfort With Anterior Versus Posterior Builds-up

U

University of Genova

Status

Unknown

Conditions

Deep Bite
Malocclusion

Treatments

Device: orthodontic - Posterior resin builds-ups
Device: orthodontic - Anterior resin builds-ups

Study type

Interventional

Funder types

Other

Identifiers

NCT04105127
RCT Builds-ups

Details and patient eligibility

About

Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment.

In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.

Enrollment

80 estimated patients

Sex

All

Ages

9 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with reduced overbite treated with orthodontic fixed appliance
  • Angle Class I, Class II or Class III malocclusion

Exclusion criteria

  • Hypodontia in any quadrant excluding third molars
  • Craniofacial syndromes, or cleft lip or palate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Anterior builds-ups
Active Comparator group
Description:
Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the palatal surfaces of central upper incisors
Treatment:
Device: orthodontic - Anterior resin builds-ups
Posterior builds-ups
Active Comparator group
Description:
Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the occlusal surfaces of first or second upper/lower molars
Treatment:
Device: orthodontic - Posterior resin builds-ups

Trial contacts and locations

1

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Central trial contact

Alessandro Ugolini, DDS Phd

Data sourced from clinicaltrials.gov

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