Acceleration of Orthodontic Tooth Movement

NCT05560919 | Completed Phase 2 DMC

• 1 other identifier: Tishreen U _Orthodontics
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.

Conditions

Mild to Moderate Anterior Mandibular Segment Crowdind

Keywords

Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch

  To calculate outcome measures, a mandible alginate impression was taken to make study casts at three time points: before insertion of the first archwire (T0), after 1 month of treatment commencement (T1), and at the end of the leveling and alignment stage (T2), represented by final archwire insertion. LII was used to measure the change in tooth alignment on the casts. It involved measuring the horizontal linear distance among adjacent contact points of the six anterior teeth. The sum of these five measurements gave the value of the index. LII was measured using a digital caliper to the nearest 0.01 mm by the corresponding author. OLAT was calculated by the number of days between T0 and T2.

  6 months

Secondary Outcomes (2)

• Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.

  6 months

• VAS scale

  3 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale

Drug: Dihydroxycholecalciferols

Group 2

EXPERIMENTAL

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale.

Other: dimethyl sulfoxide

Group 3

EXPERIMENTAL

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale.

Other: serum

Interventions

Dihydroxycholecalciferols DRUG

Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.

Group 1

dimethyl sulfoxide OTHER

Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.

Group 2

serum OTHER

Injection of serum in the periodontal ligament for lower anterior segment teeth.

Group 3

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
• Healthy patient
• No previous orthodontic treatment
• Vital teeth with periodental tissue without root absorption,

You may not qualify if:

• Previous history of orthodontic or orthopedic treatment.
• Presence of craniofacial anomalies.
• Presence of any signs and symptoms of gingival and periodontal diseases.
• Presence of significant medical history (including drug allergy).
• Pregnant and lactating women.

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Tishreen University - Faculty of dentistry

Latakia, Syria

Location

MeSH Terms

Interventions

Dihydroxycholecalciferols; Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Sulfoxides; Sulfur Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: September 20, 2021
• Primary Completion: April 30, 2022
• Study Completion: June 25, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 8 months

Locations

SY (1)