Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement

June 16, 2020 updated by: Moustafa Osama Shehata, Cairo University

Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial

Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights.

For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown.

The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines.

Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
  • Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
  • More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
  • Presence of intact adjacent teeth.

Exclusion Criteria:

  • Badly broken-down teeth with active signs of infection.
  • Teeth with vertical root fracture.
  • Teeth with severely tapered roots..
  • Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
  • Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
  • Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems, emotional instability, and unrealistic esthetic demands.
  • History of radiation therapy to the head and neck, or bone augmentation to implant site.
  • Labial cortical bone fenestration diagnosed from CBCT.
  • Bruxism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Orthodontic extrusion

An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth.

Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.
Procedure: Orthodontic extrusion

An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets "American Orthodontics Roth prescription. 0.022" slot" will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022") will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth.

Orthodontic extrusion will start using a light overlay wire of 0.012" NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs.
ACTIVE_COMPARATOR: Immediate implant placement
The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.
Procedure: Immediate implant placement
The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue outcome
Time Frame: 12 months
Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 12 months
Tooth and Implant survival
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Moustafa O Shehata, B.D.S., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (ACTUAL)

June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22042020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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