- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07300371
Intra-oral Evaluation of Force Decay of Pigmented and Transparent Elastomeric Power Chains:
December 23, 2025 updated by: Maha Saleh Mahdi Al-Muntaser, Sana'a University
Intra-oral Evaluation of Force Decay of Pigmented and Transparent Elastomeric Power Chains: A Randomized Clinical Trail.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: Matt gray elastomeric power chains
- Other: Matt blue elastomeric power chains
- Other: Matt pink elastomeric power chains
- Other: Matt transparent elastomeric power chains
- Other: Matt black elastomeric power chains
- Other: American orthodontic gray elastomeric power chains
- Other: Americam orthodontic blue elastomeric power chains
- Other: Americam orthodontic black elastomeric power chains
- Other: Americam orthodontic pink elastomeric power chains
- Other: Americam orthodontic transparent elastomeric power chains
- Other: SIA pink elastomeric power chains
- Other: SIA blue elastomeric power chains
- Other: SIA black elastomeric power chains
- Other: SIA transparent elastomeric power chains
- Other: SIA gray elastomeric power chains
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
96
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
-
-
-
Sanaa, Yemen
- Sana'a University
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Matt gray elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: Matt blue elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: Matt transparent elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: Matt black elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: American orthodocntic gray elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: American orthodontic blue elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: American orthodocntic black elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: American orthodocntic pink elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: American orthodocntic transparent elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: SIA black elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: SIA pink Elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: SIA blue Elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: SIA gray Elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: SIA transparent Elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
|
Experimental: Matt pink elastomeric power chains
EPCs were stretched between the canine bracket hook and the first molar band hook throughout the study period.
The delivered force of EPCs was measured using a Dentarum force gauge over 6-week intervals (baseline, after the 1st 24 hours, 1st week, 2nd week, 3rd week, 4th week, 5th week, and 6th week
|
Matt gray elastomeric power chains is Orthodontic auxiliary/ elastomeric power chains.
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
Orthodontic Auxiliary force generated system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and weekly for 6 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mohammed Abdullah Al-Labani, Ph degree, Sana'a University,Sana'a,Yemen.
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)
November 19, 2023
Primary Completion (Actual)
September 20, 2024
Study Completion (Actual)
September 20, 2024
Study Registration Dates
First Submitted
November 26, 2025
First Submitted That Met QC Criteria
December 9, 2025
First Posted (Estimated)
December 23, 2025
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 23, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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