Clinical trial NCT04436094: Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement
Official title: Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Broken Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Soft tissue outcome
timeFrame: 12 months
Secondary outcomes:
measure: Survival
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Moustafa O Shehata, B.D.S.
role: PRINCIPAL_INVESTIGATOR
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