Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement

Study Overview
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Brief Summary
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Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics and functional issues. This may be due to more than cause as fights, contact sports, accidents and falls. However; implant placement might not be the treatment of choice in some situations such as: medically compromised patients with absolute contraindications for implant placement or requiring extensive augmentation procedures, growing patients, patients with financial limitations, in addition to patients living in rural areas with no access for CBCT machines. Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a specific treatment modality, especially in patients having financial limitations. Regarding the aforementioned conditions, surgical extrusion might be considered a cost-effective 'often overlooked' alternative compared to immediate single-tooth implant placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion may be a good alternative yielding better soft tissue results as we preserve the natural tooth with the whole periodontium.

Official Title
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Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial

Conditions
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Broken Teeth

Intervention / Treatment
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* Procedure: Surgical Extrusion
* Procedure: Immediate Implant Placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients) Single rooted teeth; should be single 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 crown to root ratio is 1:1 after extrusion and restoration Exclusion Criteria: Badly broken-down teeth with active signs of infection. Teeth with vertical root fracture. Teeth with severely tapered root. 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. Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day). 9 History of radiation therapy and/or chemotherapy to the head and neck, or bone augmentation to implant site. Labial cortical bone fenestration diagnosed from CBCT. Patients with systemic disease that may affect normal healing. Psychiatric problems, emotional instability, and unrealistic esthetic demands. Bruxism.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Extrusion<br>The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks. | Procedure: Surgical Extrusion<br>* The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.<br>|
| Active Comparator: Immediate Implant Placement<br>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, 11 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. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft. | Procedure: Immediate Implant Placement<br>* 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, 11 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. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue outcome | 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 | Tooth and Implant survival (binary) | 12 months |