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Completed

NCT Number: NCT07300371

Intra-oral Evaluation of Force Decay of Pigmented and Transparent Elastomeric Power Chains:

This study aimed to evaluate the amount of force decay in pigmented and transparent elastomeric power chains. The principal investigator measured the amount of force decay at 7 intervals using a calibrated Dentaurum force gauge. This study also assessed the associated variables that accelerate the force loss, such as brushing frequency, beverage consumption,mastication, Khat chewing, oral , and tooth movement, . The study outcomes provide evidence-based guidance for selecting elastomeric power chains in routine orthodontic practice.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sana'a university

Sanaa, Yemen

About this study

The study was a split-mouth randomized clinical trial. Four colors (pink, blue, black, and grey) and transparent elastomeric power chains from 3 different companies (American Orthodontic, SIA, and Matt) were evaluated. A total of 96 participants were recruited, and 192 elastomeric power chains were stretched between the canine bracket hook and the molar band hook throughout the study period. The delivered force of elastomeric power chains was assessed and compared among each other using a calibrated Dentarum force gauge over 6-week intervals (baseline, 24 hours, first week, second week, third week, fourth week, fifth week, and sixth week). To further investigate factors influencing force decay (FD), data on tooth movement, mastication side, beverage consumption, brushing frequency, oral hygiene status, and khat chewing were collected using a structured questionnaire to assess their potential impact.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 12-30 years.
  • Patients who are undergoing fixed orthodontic treatment.
  • Orthodontic patients who underwent bilateral extraction protocol in maxillary arch.
  • Patients were in working arch wire 19×25 stainless steel.
  • Patients with moderate anchorage to ensure comparable baseline mechanics.

Exclusion criteria

  • Patients indicated for orthognathic treatment.
  • Patients who reported any systemic diseases.
  • Patients with clefts or syndromes.

Treatment and study plan

Matt gray elastomeric power chains

Other

Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.

Matt blue elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Matt pink elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Matt transparent elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Matt black elastomeric power chains

Other

Orthodontic Auxiliary force generated system

American orthodontic gray elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Americam orthodontic blue elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Americam orthodontic black elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Americam orthodontic pink elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Americam orthodontic transparent elastomeric power chains

Other

Orthodontic Auxiliary force generated system

SIA pink elastomeric power chains

Other

Orthodontic Auxiliary force generated system

SIA blue elastomeric power chains

Other

Orthodontic Auxiliary force generated system

SIA black elastomeric power chains

Other

Orthodontic Auxiliary force generated system

SIA transparent elastomeric power chains

Other

Orthodontic Auxiliary force generated system

SIA gray elastomeric power chains

Other

Orthodontic Auxiliary force generated system

Primary outcomes

  1. Evaluate the force decay of pigmented and transparent elastomeric power chains in a group of orthodontic patients

    Time frame: Baseline and weekly for 6 weeks.

    Measurement of the amount of force decay (in grams) for each elastomeric power chain sample at baseline and at 7 time intervals over 6 weeks using a digital force gauge.

Secondary outcomes

  1. Correlation between force decay and associated variables (tooth movement, masticating side, beverage consumption, brushing frequency, oral hygiene, and khat chewing)

    Time frame: At 6 weeks

    Correlation analysis between force decay values (in grams) and the associated variables collected through a structured questionnaire.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

Intra-oral Evaluation of Force Decay of Pigmented and Transparent Elastomeric Power Chains: A Randomized Clinical Trail.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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