Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site

NCT04598490 | Completed

• 1 other identifier: 53b/2019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to compare the rate of teeth movement into fresh and old extraction sites.

Conditions

Orthodontic Appliance

Keywords

recent; healed; extraction space

Outcome Measures

Primary Outcomes (1)

• Amount of space closure

  Width of extraction space will be measured in millimeters

  3 months

Study Arms (2)

Healed extraction site

EXPERIMENTAL

Old Extraction Space

Device: Space closure into old extraction space

unhealed extraction site

EXPERIMENTAL

Recent Extraction space

Device: Space closure into recent extraction space

Interventions

Space closure into old extraction space DEVICE

Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket

Healed extraction site

Space closure into recent extraction space DEVICE

Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket

unhealed extraction site

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥ 16 years
• Proclined upper and lower incisors (Ui/max \>115 o, Li/mand \>99o)
• Mild upper and lower arch crowding (\<4mm) or no crowding
• Need for upper and lower first premolars extraction
• Skeletal I malocclusion (1\<ANB \<5)
• Average lower facial height and maxillomandibular plane angle (22 o \<MM\<32 o)
• Class I canine relationship
• Good oral hygiene and healthy periodontium

You may not qualify if:

• Poor oral hygiene
• Diseases and medications that were likely to affect bone biology
• Previous orthodontic treatment
• Evidence of bone loss
• Active periodontal disease
• Smoking

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics

Irbid, Jordan

Location

Study Officials

• Elham S A Alhaija, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After recruiting patients who met the inclusion criteria, the intervention was randomly allocated to either the right or left side using the permuted random block size of 2 with 1:1 allocation ratio. The random sequences for each intervention to either right or left sides was concealed in opaque envelopes and shuffled before the intervention to increase the unpredictability of the random allocation sequence. Each patient was asked to pick a sealed envelope to assign the intervention to either the right or left side. Allocation concealment was aimed to prevent selection bias and to protect the assignment sequence until allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Space closure into old extraction space

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: August 1, 2020
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)