Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars

Effect of Extraction Versus Non-extraction Orthodontic Treatment on the Third Molars: A Non-Randomized Clinical Trial /a Prospective Clinical Trial

What is the effect of extraction orthodontic treatment in comparison to non- extraction treatment on the position, inclination and incidence of impaction of the third molars?

Study Overview

• Status: Active, not recruiting
• Conditions: Orthodontic Treatment Via Premolar Extraction
• Intervention / Treatment: Procedure: extraction orthodontic treatment plan

Detailed Description

Data regarding the personal information (name, age and gender), chief complaint, medical and dental history will be taken. Medical history questionnaire will be filled by the patient to exclude the presence of any systemic conditions.

complete set of orthodontic records will be taken; Pre- operative records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic & lateral cephalogram). After formulating the best treatment plan for each patient, All patients will be enrolled into one of two groups: Intervention Group (I) : Extraction treatment group. Comparator group (C): Non-extraction group. Following the end of treatment, Post-treatment records including (standardized intra- and extra-oral photographs, primary impression for study model, panoramic & lateral cephalogram) will be taken.

Primary outcome: The angulation of the mandibular third molars.Secondary outcomes:

1. space available for the upper and lower third molar.
2. Angulation of the third molar.
3. The vertical position of the third molars.
4. the mineralization status of the third molars

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12588
    • Amira Aboalnaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adolescent males and females (14-18 years) with Bilaterally unerupted developing third molars. Not more than two thirds of the root development of the third molars had taken place.

  • Dental Class I malocclusion cases requiring four premolar extraction with a moderate anchorage requirement.
  • low or increased vertical dimension.

Exclusion Criteria:

• Premolar extraction cases requiring maximum anchorage preparation.

  • Low vertical dimension.
  • patients without dentofacial deformities, severe facial asymmetries, or missing teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: extraction treatment; patients will be referred for extraction of the upper and lower first premolars to relieve the crowding.	Procedure: extraction orthodontic treatment plan; patients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow.
No Intervention: non-extraction treatment; Leveling and alignment of the moderate crowding will be performed through a recall visits of 4 weeks for wire activation. inter-proximal reduction step might be done if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
third molar angulation	The angulation of the mandibular third molars	at the end of orthodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
space available for the upper and lower third molar	space available for the upper and lower third molar	at the end of orthodontic treatment
Angulation of the third molar.	Angulation of the third molar.	at the end of orthodontic treatment
The vertical position of the third molars	The vertical position of the third molars	at the end of orthodontic treatment
the mineralization status of the third molars	the mineralization status of the third molars	at the end of orthodontic treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: amira aboalnaga, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): March 4, 2023
• Study Completion (Estimated): December 10, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: third molar impaction, third molar angulation, third molar vertical position
• Other Study ID Numbers: CEBD-CU-2021-10-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the pre-treatment and post-treatment records

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No