External Root Resorption and Periodontal Status During Retraction of the Upper Anterior Teeth

NCT06873490 | Completed DMC

• 1 other identifier: UDDS-Ortho-2-2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT will include 34 patients requiring en-masse retraction of upper anterior teeth after maxillary first premolars extraction. Patients accepted into the study will be randomly assigned to one of two groups in a 1:1 allocation ratio: the electrically stimulated en-masse retraction group (ESER) and the conventional en-masse retraction group (CER). In both groups, the upper anterior teeth will be retracted en masse by applying 250 g of force on each side using closed nickel-titanium coil springs. Mini-implants will be used to provide the maximum anchorage. The outcomes of the study will be the external apical root resorption (EARR) and the periodontal status of the upper anterior teeth during the treatment stages.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (1)

• Change in external apical root resorption

  The root length will be measured for each root of six upper anterior teeth. The method originally described by Linge and Linge will be used. The amount of root resorption (in millimeters) will be calculated using the following equation: Root Resorption = Root Length (T0) - (Root Length (T1) × Correction Factor). The Correction Factor will be calculated by dividing the crown Length (T0) to the crown Length (T1).

  The digital panoramic radiographs will be taken at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).

Secondary Outcomes (4)

• Change in the Gingival Index

  Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).

• Change in the Dental Plaque index

  Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).

• Change in the Bleeding Index

  Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).

• Change in Gingival Recession

  Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).

Study Arms (2)

Electric stimulation with retraction

EXPERIMENTAL

Electric current will be applied in this group of patients using a removable device.

Device: Electric stimulation removabel device

Traditional retraction

ACTIVE COMPARATOR

No acceleration method will be performed in this group. Only the traditional method of retraction will be followed.

Procedure: Traditional retraction method.

Interventions

Electric stimulation removabel device DEVICE

The device will be used to stimulate orthodontic tooth movement through a specific design used to deliver the current to the mucosa around the teeth being retracted.

Electric stimulation with retraction

Traditional retraction method. PROCEDURE

In this intervention, the upper anterior teeth will be retracted together backward using the traditional retraction method. No acceleration devices will be used in conjunction with this procedure.

Traditional retraction

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adult patients, Male and female, Age range: 18-25 years.
• Class II Division 1 malocclusion :
• Mild/moderate skeletal Class II (ANB= 5-7 degrees)
• Overjet ≤10
• Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
• Permanent occlusion.
• The Existence of all the upper teeth (except third molars).
• Good oral and periodontal health:
• Probing depth \< 4 mm
• No radiographic evidence of bone loss.
• Gingival index ≤ 1
• Plaque index ≤ 1

You may not qualify if:

• Medical problems that affect tooth movement, such as corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs).
• Presence of primary teeth in the maxillary arch
• Missing permanent maxillary teeth (except third molars).
• Poor oral hygiene or Current periodontal disease:
• Probing depth ≥ 4 mm Radiographic evidence of bone loss Gingival index \> 1 Plaque index \> 1
• Patient had previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

Location

Related Publications (5)

• Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.

  PMID: 37234453 BACKGROUND

• Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.

  PMID: 6243448 BACKGROUND

• Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.

  PMID: 26917494 BACKGROUND

• Shaadouh RI, Hajeer MY, Awawdeh MA, Jaber ST, Mahmoud GA, Almasri IA. Effectiveness of low-intensity electrical current in accelerating the en-masse retraction of the upper anterior teeth following first-premolar extraction in young adult patients with Class II division 1 malocclusion: A randomized controlled clinical trial. Int Orthod. 2024 Dec;22(4):100921. doi: 10.1016/j.ortho.2024.100921. Epub 2024 Sep 23.

  PMID: 39316889 BACKGROUND

• Shaadouh RI, Hajeer MY, Alam MK, Jaber ST. Effect of Low-Intensity Electrical Stimulation on External Apical Root Resorption and Periodontal Indices Following En-Masse Retraction of Upper Anterior Teeth in Young Adults: A Randomized Controlled Trial. Clin Exp Dent Res. 2025 Aug;11(4):e70188. doi: 10.1002/cre2.70188.

  PMID: 40762524 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rashad Ibrahem Shaadouh, DDS MSc

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: November 1, 2023
• Primary Completion: March 13, 2024
• Study Completion: December 15, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)