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

Broken Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04436094
• Other study ID #: 22042020
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: September 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Moustafa O Shehata, B.D.S.
• Phone: 00201225897482
• Email: moustafa.hassan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Broken Teeth
• Tooth Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (19)

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue outcome	Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value	12 months
Secondary	Survival	Tooth and Implant survival	12 months