Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510621
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
The Preliminary Application of Socket-shield Technique in Orthodontic Extraction and Fixed Orthodontic Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Preliminary Application of Socket-shield Technique in Orthodontic Extraction and Fixed Orthodontic Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background This study was conducted to investigate the clinical efficacy of Socket-Shield Technique on the first premolar bone preservation in Orthodontic Extraction Treatment
Methods 26 patients 12 males 14 females 36 single-jaw from June 2018 to June 2021 who were underwent Orthodontic Extraction Treatment in the First Affiliated Hospital of Guangzhou Medical University were enrolled Extracted teeth were paired and randomly allocated into two groups test group Socket-Shield Technique and control group Cone beam computerized tomography were utilized to access the horizontal resorption and vertical resorption at 1mm 3mm and 5mm from a reference plane of alveolar crest as well as tooth movement rate at four time-points before tooth extraction T0 three months after tooth extraction T1 the juncture socket-shield was removed T2 and three months after socket-shield removal T3
Methods 26 patients 12 males 14 females 36 single-jaw from June 2018 to June 2021 who were underwent Orthodontic Extraction Treatment in the First Affiliated Hospital of Guangzhou Medical University were enrolled Extracted teeth were paired and randomly allocated into two groups test group Socket-Shield Technique and control group Cone beam computerized tomography were utilized to access the horizontal resorption and vertical resorption at 1mm 3mm and 5mm from a reference plane of alveolar crest as well as tooth movement rate at four time-points before tooth extraction T0 three months after tooth extraction T1 the juncture socket-shield was removed T2 and three months after socket-shield removal T3
Detailed Description:
21 Participants This study was conducted following the Declaration of Helsinki the Consolidates Standards of Reporting Trials CONSORT and the Good Clinical Practice GCP guideline The protocol was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University Approval No 2018-27 All patients were informed and agreed to provide informed consent and their data for further analysis and publication Additionally for minors participating in the study informed consent was obtained from a parent or legal guardian
Patients were included in the study if they reached all of the following criteria 1 had an orthodontic treatment plan involving the extraction of symmetrical left and right first premolars 2 had maxillary protrusion or bimaxillary protrusion with crowding within 4mm 3 had permanent dentition 4 had good oral hygiene and had no periodontitis and 5 agreed to the orthodontic extraction treatment plan and signed the treatment informed consent form and the experimental informed consent form
The study exclusion criteria were as follows 1 underlying diseases such as hypertension heart disease diabetes osteoporosis or hyperthyroidism 2 infection in the extraction area 3 dental root caries in the extraction area 4 gingival recession on the buccal aspect of the extraction area 5 refused to undergo SST treatments and 6 pregnancy or lactation
22 Surgical procedure Test Group SST A high-speed turbine was used to cut the tooth crown 15-2 mm from the buccal gingival margin Figure 1a 1b The tooth was then divided along the long axis approximately 2 mm from the buccal sideFigure 1c 1d The palatal roots were removed using minimally invasive elevation and extraction forceps Next the buccal socket-shield was trimmed to approximately 4-6 mm in height 1 mm from the buccal gingival margin18 3-4 mm in width and 1-15 mm in thickness The trimming process required with clear visualization of the shield and calibration by periodontal probe Finally the socket-shield was removed by minimally invasive forceps when the adjacent tooth moved proximate to the shield during the process of closing orthodontic gap
Control Group non-SST The same technique was used to cut the crown divide the root remove the palatal root trim the socket-shield and extract the shield immediately
After the tooth extraction patients were prescribed clindamycin and ibuprofen sustained-release capsules instructed to use oral rinse and received oral health education Fixed orthodontic treatment with straight wire AO self-ligating brackets 0022 x 0028 inch slot Empower Philosophies American Orthodontics Sheboygan USA was used The alignment and leveling procedures typically lasted three to four months Subsequently the orthodontic gap was closed by a 0019 x 0025 inch 048 mm x 064 mm stainless steel square wire with a force gauge to control the sliding force value at approximately 150 g
During orthodontic follow-up the mobility of socket-shield as well as clinical manifestations such as color texture and bleeding of gingiva were evaluated to assess the clinical condition of the socket-shield
23 Measurement methods In order to evaluate the clinical effects of SST and non-SST on alveolar bone width and height at the extraction site in the first premolar area the left and right first premolars in same jaw were paired and randomly assigned to the test group SST or the control group non-SST The time points prior to tooth extraction three months after tooth extraction when the socket-shield extracted and three months after socket-shield extraction were marked as T0 T1 T2 and T3 respectively Cone beam computerized tomography CBCT scans 120 kVp and 1866 mAs voxel size 03 Alpha Plus RCT700-SC RayScan Hwaseong-si Korea were taken at each time point T01 was defined as the interval from T0 to T1 T02 as T0 to T2 T12 as T1 to T2 T03 as T0 to T3 and T23 as T2 to T3
Three-dimensional coordinate systems were established by CBCT data in Invivo Dental 50 software Anatomage Inc Milan Italy to measure the alveolar bone height and width21
The most anterior-inferior point of the left mental foramen was defined as the origin the line parallel to the line connecting the most anterior-inferior points of two mental foramina as the X-axis and line parallel to the inferior border of the left mandible as the Y axes Then a three-dimensional coordinate system for the left mandible was established A symmetric coordinate was established for the right mandible
The most anterior point of the anterior nasal spine was set as the origin the line parallel to the line connecting the lowest points of both maxillary sinus as the X-axis and the line parallel to the palatal plane as Y-axis Then a three-dimensional coordinate system for the maxilla was established
To ensure the consistency of the measurements at each time point a cross-section parallel to the XZ plane through the lowest point of the alveolar crest was defined as the reference plane at T0 At T0 T1 T2 and T3 the Z value of the lowest point of the alveolar crest was recorded as alveolar bone height and X value at 1 mm 3 mm and 5 mm from the reference plane was recorded as width denoted as H0W0135 H1W1135 H2W2135 and H3W3135 respectively The the changes of height and width can be calculated as follows ΔH1H1-H0ΔW1W1-W0 during T01 ΔH2H2-H0ΔW2W2-W0 during T02 and ΔH3H3-H0ΔW3W3-W0 during T03
CBCT three-dimensional reconstruction graphics were used to measure the distance between the most convex points of the adjacent teeth in the mesial and distal distance of the orthodontic gap Data at T1 T2 and T3 were recorded as D1 D2 and D3 respectively Tooth movement rate can be calculated by dividing tooth movement distance in mm by the time taken for orthodontic gap closing in months D1-D2T2-T1 during T12 and D2-D3T3-T2 during T23
All measurement were performed by two doctors who underwent standardized training The data was subjected to a qualitative consistency test the intraclass correlation coefficient ICC Only when ICC075 the average of the two measurements was used as the final result
Patients were included in the study if they reached all of the following criteria 1 had an orthodontic treatment plan involving the extraction of symmetrical left and right first premolars 2 had maxillary protrusion or bimaxillary protrusion with crowding within 4mm 3 had permanent dentition 4 had good oral hygiene and had no periodontitis and 5 agreed to the orthodontic extraction treatment plan and signed the treatment informed consent form and the experimental informed consent form
The study exclusion criteria were as follows 1 underlying diseases such as hypertension heart disease diabetes osteoporosis or hyperthyroidism 2 infection in the extraction area 3 dental root caries in the extraction area 4 gingival recession on the buccal aspect of the extraction area 5 refused to undergo SST treatments and 6 pregnancy or lactation
22 Surgical procedure Test Group SST A high-speed turbine was used to cut the tooth crown 15-2 mm from the buccal gingival margin Figure 1a 1b The tooth was then divided along the long axis approximately 2 mm from the buccal sideFigure 1c 1d The palatal roots were removed using minimally invasive elevation and extraction forceps Next the buccal socket-shield was trimmed to approximately 4-6 mm in height 1 mm from the buccal gingival margin18 3-4 mm in width and 1-15 mm in thickness The trimming process required with clear visualization of the shield and calibration by periodontal probe Finally the socket-shield was removed by minimally invasive forceps when the adjacent tooth moved proximate to the shield during the process of closing orthodontic gap
Control Group non-SST The same technique was used to cut the crown divide the root remove the palatal root trim the socket-shield and extract the shield immediately
After the tooth extraction patients were prescribed clindamycin and ibuprofen sustained-release capsules instructed to use oral rinse and received oral health education Fixed orthodontic treatment with straight wire AO self-ligating brackets 0022 x 0028 inch slot Empower Philosophies American Orthodontics Sheboygan USA was used The alignment and leveling procedures typically lasted three to four months Subsequently the orthodontic gap was closed by a 0019 x 0025 inch 048 mm x 064 mm stainless steel square wire with a force gauge to control the sliding force value at approximately 150 g
During orthodontic follow-up the mobility of socket-shield as well as clinical manifestations such as color texture and bleeding of gingiva were evaluated to assess the clinical condition of the socket-shield
23 Measurement methods In order to evaluate the clinical effects of SST and non-SST on alveolar bone width and height at the extraction site in the first premolar area the left and right first premolars in same jaw were paired and randomly assigned to the test group SST or the control group non-SST The time points prior to tooth extraction three months after tooth extraction when the socket-shield extracted and three months after socket-shield extraction were marked as T0 T1 T2 and T3 respectively Cone beam computerized tomography CBCT scans 120 kVp and 1866 mAs voxel size 03 Alpha Plus RCT700-SC RayScan Hwaseong-si Korea were taken at each time point T01 was defined as the interval from T0 to T1 T02 as T0 to T2 T12 as T1 to T2 T03 as T0 to T3 and T23 as T2 to T3
Three-dimensional coordinate systems were established by CBCT data in Invivo Dental 50 software Anatomage Inc Milan Italy to measure the alveolar bone height and width21
The most anterior-inferior point of the left mental foramen was defined as the origin the line parallel to the line connecting the most anterior-inferior points of two mental foramina as the X-axis and line parallel to the inferior border of the left mandible as the Y axes Then a three-dimensional coordinate system for the left mandible was established A symmetric coordinate was established for the right mandible
The most anterior point of the anterior nasal spine was set as the origin the line parallel to the line connecting the lowest points of both maxillary sinus as the X-axis and the line parallel to the palatal plane as Y-axis Then a three-dimensional coordinate system for the maxilla was established
To ensure the consistency of the measurements at each time point a cross-section parallel to the XZ plane through the lowest point of the alveolar crest was defined as the reference plane at T0 At T0 T1 T2 and T3 the Z value of the lowest point of the alveolar crest was recorded as alveolar bone height and X value at 1 mm 3 mm and 5 mm from the reference plane was recorded as width denoted as H0W0135 H1W1135 H2W2135 and H3W3135 respectively The the changes of height and width can be calculated as follows ΔH1H1-H0ΔW1W1-W0 during T01 ΔH2H2-H0ΔW2W2-W0 during T02 and ΔH3H3-H0ΔW3W3-W0 during T03
CBCT three-dimensional reconstruction graphics were used to measure the distance between the most convex points of the adjacent teeth in the mesial and distal distance of the orthodontic gap Data at T1 T2 and T3 were recorded as D1 D2 and D3 respectively Tooth movement rate can be calculated by dividing tooth movement distance in mm by the time taken for orthodontic gap closing in months D1-D2T2-T1 during T12 and D2-D3T3-T2 during T23
All measurement were performed by two doctors who underwent standardized training The data was subjected to a qualitative consistency test the intraclass correlation coefficient ICC Only when ICC075 the average of the two measurements was used as the final result
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None