Repair of Orthodontically-induced Tooth Root Resorption by Ultrasound

NCT00423956 | Unknown Phase 1 DMC

• 1 other identifier: 6203
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Tooth-root resorption, also known as shortening or erosion,(TRR) is one of the adverse outcomes of dental trauma, orthodontic tooth movement and dental replantation/transplantation. Orthodontically induced inflammatory root resorption (OIIRR) is somewhat different from other types of TRR. The treatment protocol of teeth diagnosed with severe OIIRR or other forms of TRR always involves root canal treatment or extraction of these teeth in severe cases and prosthetic replacement. Sometimes teeth with minor TRR may stay for an extended period of time with compromised bite functions. Although several trials have been proposed to minimize or prevent TRR or OIIRR, none is capable of being used in clinical situation to treat TRR or OIIRR in humans except for Low Intensity Pulsed Ultrasound (LIPUS). However, research examining the use of LIPUS to treat OIIRR has been limited to simple orthodontic tooth tipping. In reality, tooth movement is a combination of different types of tooth movements, namely tipping, bodily, rotational, torque, intrusion and extrusion tooth movements. However, the literature have pointed out that torque tooth movement, especially when the root apices are torques against cortical plates of bone produces the most dramatic type of tooth root resorption with poor prognosis. Our long-term goal is to develop a standard protocol for treating severe tooth root resorption with poor prognosis in humans, regardless of origin. Our preliminary data demonstrates that LIPUS can produce healing of OIIRR in humans after simple tipping movement, this was confirmed by an in-vitro study on isolated cementoblasts. The objective of the present proposal is to evaluate the effect of different treatment protocols of LIPUS on the healing process of orthodontically induced tooth-root resorption due to torque (Complex)type of tooth movement in humans. The study Hypotheses are (I) LIPUS treatment for 20 minutes per day for 4 weeks will be effective in repairing OIIRR due to torque tooth movement. (II) The stimulatory effect of LIPUS to repair OIIRR due to torque tooth movement than LIPUS treatment is dose and time dependent.

Conditions

Root Resorption

Keywords

Teeth root resorption, ultrasound, therapy

Outcome Measures

Primary Outcomes (3)

• Evaluation of the effect of LIPUS on OITRR

  Four weeks

• Teeth Root length

  four weeks

• Root resorption lacunae number and volume

  Four weeks

Secondary Outcomes (2)

• Study the effect of LIPUS on alveolar bone remodeling

  Four weeks

• Rate of tooth movement

  Rate of tooth movement at the time of extraction

Study Arms (1)

Sham Comparator

SHAM COMPARATOR

One side is experimental and the opposite side is Sham control.

Procedure: Repairing Induced tooth root resorption by ultrasound

Interventions

Repairing Induced tooth root resorption by ultrasound PROCEDURE

Repairing Induced tooth root resorption by ultrasound

Sham Comparator

Eligibility Criteria

• Age: 12 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All the root apices of the experimental premolars should be completed.
• All experimental premolars should be sound and have no history of trauma/caries or root canal therapy.

You may not qualify if:

• Patients with incomplete experimental premolars' apices.
• Any patient with experimental premolars that have a history of trauma/caries or root canal therapy.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta, Graduate Orthodontic program

Edmonton, Alberta, T6G 2N8, Canada

RECRUITING

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dr. Tarek H El-Bialy, PhD

  University of Alberta, Edmonton, AB, Canada

  STUDY CHAIR

Central Study Contacts

Dr. Tarek H El-Bialy, PhD

CONTACT

1-780-492-2751; telbialy@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

CA (1)