Effectiveness of 3D-guided piezocision-assisted orthodontic surgery (a minimally invasive surgical technique) in accelerating the correction of severely crowded teeth

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: With the aid of a computer‐generated list of random numbers, the recruited patients will be assigned to two parallel groups with a 1:1 allocation ratio. The first group receive conventional orthodontic treatment, whereas the second group receive piezocision‐assisted orthodontic treatment. The allocation sequence will be concealed using sequentially numbered, opaque, sealed envelopes. Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding. The device tip will be used to create small vertical incisions into the cortex of the dentoalveolar process of the lower anterior teeth guided by a 3D surgical guide. For the control group, traditional orthodontic treatment will be provided to the patients without any surgical interventions. The duration of orthodontic treatments differs from one patient to another, they will be followed up until the end of the alignment phase. CONDITION: Anterior teeth severe orthodontic crowding ; Oral Health ; Anomalies of tooth position PRIMARY OUTCOME: ; 1. Duration of tooth alignment measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120‐150 days of observation; 2. Change in tooth alignment measured using the Little Index of Irregularity at 30 days after the onset of treatment; 3. Change in tooth alignment measured using the Little Index of Irregularity at 60 days after the onset of treatment; 4. Change in tooth alignment measured using the Little Index of Irregularity at last assessment when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment; SECONDARY OUTCOME: ; 1. Pain measured using the visual analogue score (VAS) at baseline, 12, 24 and 48 hours; 2. Discomfort measured using the visual analogue score (VAS) at baseline, 12, 24 and 48 hours; 3. Swelling measured using the visual analogue score (VAS) at baseline, 12, 24 and 48 hours; INCLUSION CRITERIA: 1. Adult healthy patients, male and female, age range 15‐27 years 2. Severe crowding =7 (Little's irregularity index) 3. Permanent occlusion 4. All mandibular teeth exist (except third molars) 5. Good oral and periodontal health: 5.1. Probing depth <4 mm 5.2. No radiographic evidence of bone loss 5.3. Gingival index =1 5.4. Plaque index =1
Epistemonikos ID: 00ab5b9deb6e89e749201f00a580004c6b591e6c
First added on: Aug 25, 2024