Back to resultsClinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)
Primary Purpose
Skeletal and Dental CL I Malocclusion Moderate Crowding
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Damon Ultima bracket
Sponsored by
About this trial
This is an interventional treatment trial for Skeletal and Dental CL I Malocclusion Moderate Crowding
Eligibility Criteria
Inclusion Criteria: 15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics. Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment. Presence of all the permanent teeth apart from the third molars. Patients with good oral hygiene and periodontal health. Without previous orthodontic treatment/ functional appliances Exclusion Criteria: Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery. • Patients who have cleft lip or palate, hypodontia, or hyperdontia
Sites / Locations
- Nawar A jeboryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Damon Ultima brackets
conventional Roth appliance
Arm Description
Damon Ultima brackets
conventional Roth appliance
Outcomes
Primary Outcome Measures
Occlusal outcomes assessment
1. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores < 0.5 = 0. 0.5 to 1 mm =1. > 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete.
SO:
the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome
Little Irregularity index:
This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study.
initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come
Arch parameter measurement:
Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch
Root alingment
Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed
Root resorption
Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.
Secondary Outcome Measures
Patient experience and satisfaction
The pain perception will be assessed using visual analog scale (VAS) immediately after wire insertion, at 4, 24 hours, 3 days, 7 days, and immediately after each monthly visit (0 no pain, 3 simple pain, 100 very sever pain).
Pain sensitivity questionnaire (PSQ) will be used to assess the patient reliability to pain. This will be done using the Arabic version of PSQ (The patient answer no or yes)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05978817
Brief Title
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)
Official Title
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.
Detailed Description
Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal and Dental CL I Malocclusion Moderate Crowding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Damon Ultima brackets
Arm Type
Experimental
Arm Description
Damon Ultima brackets
Arm Title
conventional Roth appliance
Arm Type
Experimental
Arm Description
conventional Roth appliance
Intervention Type
Device
Intervention Name(s)
Damon Ultima bracket
Other Intervention Name(s)
conventional Roth appliance
Intervention Description
It is metal twin bracket with their recommended arch wire
Primary Outcome Measure Information:
Title
Occlusal outcomes assessment
Description
1. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores < 0.5 = 0. 0.5 to 1 mm =1. > 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete.
SO:
the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome
Time Frame
1 year
Title
Little Irregularity index:
Description
This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study.
initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come
Time Frame
6 months
Title
Arch parameter measurement:
Description
Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch
Time Frame
1 year
Title
Root alingment
Description
Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed
Time Frame
1 year
Title
Root resorption
Description
Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient experience and satisfaction
Description
The pain perception will be assessed using visual analog scale (VAS) immediately after wire insertion, at 4, 24 hours, 3 days, 7 days, and immediately after each monthly visit (0 no pain, 3 simple pain, 100 very sever pain).
Pain sensitivity questionnaire (PSQ) will be used to assess the patient reliability to pain. This will be done using the Arabic version of PSQ (The patient answer no or yes)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics.
Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment.
Presence of all the permanent teeth apart from the third molars.
Patients with good oral hygiene and periodontal health.
Without previous orthodontic treatment/ functional appliances
Exclusion Criteria:
Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.
• Patients who have cleft lip or palate, hypodontia, or hyperdontia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nawar A jebory, PHD student
Phone
07809752102
Ext
Iraq/ Baghdad
Email
nooorznawar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dheaa H Al-Groosh, PHD
Phone
07737776503
Ext
Iraq /Baghdad
Email
dheaaha73@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dheaa H Al-Groosh, PHD
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nawar A jebory
City
Baghdad
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nawar A jebory
Phone
07809752102
Email
nooorznawar@gmail.com
First Name & Middle Initial & Last Name & Degree
Dheaa H Al-Groosh
Phone
+9647737776503
Email
dheaaha73@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
randomized clinical trial
Learn more about this trial
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)
We'll reach out to this number within 24 hrs