Pain and Discomfort and Periodontal Status in Two Acceleration Methods of Canine Retraction
Primary Purpose
Class II Malocclusion
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Piezosurgery
Low-level laser therapy
Traditional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Class II Malocclusion focused on measuring Piezosurgery, Diode laser, low-level laser, Pain
Eligibility Criteria
Inclusion Criteria:
- Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
- Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
- Overjet ≤10
- Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
- Mild to moderate crowding ≤ 4
- Permanent occlusion.
- Existence of all the upper teeth (except third molars).
Good oral and periodontal health:
- Probing depth < 4 mm
- No radiographic evidence of bone loss.
- Gingival index ≤ 1
- Plaque index ≤ 1
Exclusion Criteria:
- Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
- radiographic evidence of bone loss
- Gingival index > 1
- Plaque index > 1
- Patient had previous orthodontic treatment
Sites / Locations
- University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Piezosurgery
Low-level laser therapy
Traditional treatment
Arm Description
Piezocision will be applied in this group of patients using a piezosurgery knife.
Low-level laser therapy will be applied in this group of patients using a diode laser device.
No acceleration method will be performed in this group.
Outcomes
Primary Outcome Measures
Change in the levels of pain
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of discomfort
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of swelling
Assessment will be performed using questionnaires via Visual Analog scale.
Levels of Eating difficulty
Assessment will be performed using questionnaires via Visual Analog scale.
Change in the levels of satisfaction
Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.
Secondary Outcome Measures
The change in the plaque index
Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of oral hygiene in enrolled patients.
A. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth.
C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket.
D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.
The change in the gingival index
Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing.
C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing.
D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding.
The change in the bleeding index
Assessment will be achieved using a gingival probe according to Muhlemann (1977) to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears.
D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
The change in the probing depth
Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus around the maxillary laterals, canines, and 2nd premolars.
Full Information
NCT ID
NCT05265416
First Posted
February 14, 2022
Last Updated
February 7, 2023
Sponsor
Damascus University
1. Study Identification
Unique Protocol Identification Number
NCT05265416
Brief Title
Pain and Discomfort and Periodontal Status in Two Acceleration Methods of Canine Retraction
Official Title
Comparison Between the Effect of Piezocision and Low-level Laser Therapy on Patient-centered Outcomes and Periodontal Health in Patients Undergoing Upper Canine Retraction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
58 patients who need extraction-based treatment of the maxillary first premolars with subsequent retraction of the maxillary canines will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.
There are three groups:
The first group (control group): the canine retraction in this group will be performed in conventional method.
The second group (Experimental group): the canine retraction in this group will be performed in association with piezocision.
The third group (Experimental group): the canine retraction in this group will be performed in association with low-level laser therapy.
Detailed Description
Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.
Regarding the Piezocision, three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
Regarding the low-level laser therapy (LLLT): GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal. The middle of the extraction site will be also irradiated in 4 sites (2 buccally and 2 palatally). The LLLT will be applied 5 times in the first month of canine retraction. After that, until the class I canine relationship will be achieved, the irradiation will be repeated every two weeks.
The levels of pain and discomfort will be self-reported using a questionnaire with visual analog scales administered at five evaluation times during the first month of canine retraction.
Periodontal health will be assessed at the beginning of orthodontic treatment, before and after canine retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, and probing depth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion
Keywords
Piezosurgery, Diode laser, low-level laser, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piezosurgery
Arm Type
Experimental
Arm Description
Piezocision will be applied in this group of patients using a piezosurgery knife.
Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
Low-level laser therapy will be applied in this group of patients using a diode laser device.
Arm Title
Traditional treatment
Arm Type
Active Comparator
Arm Description
No acceleration method will be performed in this group.
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery
Intervention Description
Three vertical incisions will be made (3-mm depth and 8-10 mm length) after anesthesia. The cuts will be performed mesial and distal the upper canine as well as at an equal distance from the upper canine and 2nd premolar.
Intervention Type
Other
Intervention Name(s)
Low-level laser therapy
Intervention Description
GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) will be applied around the upper canine in 10 sites from buccal and palatal.
Intervention Type
Device
Intervention Name(s)
Traditional treatment
Intervention Description
The canine retraction in this group will be performed in conventional method. Closed nickel-titanium coil springs applying 150 g of force per side will be used for retraction of the upper canine.
Primary Outcome Measure Information:
Title
Change in the levels of pain
Description
Assessment will be performed using questionnaires via Visual Analog scale.
Time Frame
T1: the day of the commencement of the retraction, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Title
Change in the levels of discomfort
Description
Assessment will be performed using questionnaires via Visual Analog scale.
Time Frame
T1: the day of the commencement of the retraction, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Title
Change in the levels of swelling
Description
Assessment will be performed using questionnaires via Visual Analog scale.
Time Frame
T1: the day of the commencement of the retraction, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Title
Levels of Eating difficulty
Description
Assessment will be performed using questionnaires via Visual Analog scale.
Time Frame
T1: the day of the commencement of the retraction, T2: 3 days, T3: 7 days, T4: 14 days, and T5: 28 days following the commencement of the retraction.
Title
Change in the levels of satisfaction
Description
Assessment will be performed using questionnaires via Visual Analog scale and Two-point scale: (1) Yes (2) No.
Time Frame
T5: 28 days following the commencement of the retraction.
Secondary Outcome Measure Information:
Title
The change in the plaque index
Description
Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of oral hygiene in enrolled patients.
A. (0) = No plaque. B. (1) = A film of plaque stuck to the free gingival margin and adjacent area of the tooth.
C. (2) = Moderate accretion of soft deposits on the tooth and gingival margin or within the gingival pocket.
D. (3) = Abundance of soft material on the tooth and gingival margin and/or within the gingival pocket.
Time Frame
T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
Title
The change in the gingival index
Description
Assessment will be achieved using a gingival probe according to Silness and Loe (1964) to assess the status of the gingival tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
A. (0) = Normal gingiva. B. (1) = Mild inflammation: minor change in color, slight oedema. No bleeding on probing.
C. (2) = Moderate inflammation: redness, oedema and glazing and bleeding on probing.
D. (3) = Sever inflammation: marked redness and oedema, ulceration, and tendency to spontaneous bleeding.
Time Frame
T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
Title
The change in the bleeding index
Description
Assessment will be achieved using a gingival probe according to Muhlemann (1977) to assess the status of periodontal tissues around the upper teeth (from the 2nd premolar to the contralateral 2nd premolar).
A. (0) = No bleeding. B. (1) = A single discreet bleeding point appears. C. (2) = Several isolated bleeding points or a single fine line of blood appears.
D. (3) = The interdental triangle fills with blood shortly after probing. E. (4) = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Time Frame
T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
Title
The change in the probing depth
Description
Assessment will be achieved using a gingival probe according to Miller (1985) It will be measured clinically as the distance from the free gingival margin to the gingival sulcus around the maxillary laterals, canines, and 2nd premolars.
Time Frame
T0: immediately before applying the fixed appliance; T1: one day before the commencement of the retraction phase; T2: at the end of the retraction phase which is expected to occur between 3 and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
Overjet ≤10
Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
Mild to moderate crowding ≤ 4
Permanent occlusion.
Existence of all the upper teeth (except third molars).
Good oral and periodontal health:
Probing depth < 4 mm
No radiographic evidence of bone loss.
Gingival index ≤ 1
Plaque index ≤ 1
Exclusion Criteria:
Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …)
Presence of primary teeth in the maxillary arch
Missing permanent maxillary teeth (except third molars).
Poor oral hygiene or Current periodontal disease:
Probing depth ≥ 4 mm
radiographic evidence of bone loss
Gingival index > 1
Plaque index > 1
Patient had previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doa'a Tahseen Alfailany, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32909702
Citation
Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
Results Reference
background
PubMed Identifier
24326120
Citation
Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
Results Reference
background
PubMed Identifier
25989211
Citation
Aksakalli S, Calik B, Kara B, Ezirganli S. Accelerated tooth movement with piezocision and its periodontal-transversal effects in patients with Class II malocclusion. Angle Orthod. 2016 Jan;86(1):59-65. doi: 10.2319/012215-49.1. Epub 2015 May 19.
Results Reference
background
PubMed Identifier
34984554
Citation
Keser E, Naini FB. Accelerated orthodontic tooth movement: surgical techniques and the regional acceleratory phenomenon. Maxillofac Plast Reconstr Surg. 2022 Jan 5;44(1):1. doi: 10.1186/s40902-021-00331-5.
Results Reference
background
PubMed Identifier
32255919
Citation
Farid KA, Eid AA, Kaddah MA, Elsharaby FA. The effect of combined corticotomy and low level laser therapy on the rate of orthodontic tooth movement: split mouth randomized clinical trial. Laser Ther. 2019 Dec 31;28(4):275-283. doi: 10.5978/islsm.19-OR-19.
Results Reference
background
PubMed Identifier
30991984
Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Results Reference
background
Learn more about this trial
Pain and Discomfort and Periodontal Status in Two Acceleration Methods of Canine Retraction
We'll reach out to this number within 24 hrs