Soft and Hard Tissue Changes After Immediate Single-tooth Replacement

Study Overview
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Brief Summary
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A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).

Detailed Description
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All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group Implant+CTG a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.

Official Title
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Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft

Conditions
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Implant

Intervention / Treatment
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* Procedure: Immediate dental implant placement
* Procedure: Immediate dental implant placement with CTG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar patient in good systemic health, with no contraindication for oral surgical interventions Exclusion Criteria: patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes) assumption of bisphosphonate smoking more than 10 cigarettes a day

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Implant<br>Immediate dental implant placement | Procedure: Immediate dental implant placement<br>* Tooth will be extracted and a dental implant will be positioned at the same time.<br>|
| Experimental: Implant+CTG<br>Immediate dental implant placement with CTG. | Procedure: Immediate dental implant placement with CTG<br>* Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric buccal bone changes | Ratio scale - lower values represent a better outcome | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric buccal soft tissue changes | Ratio scale - higher values represent a better outcome | 6 months | 
| Buccal soft tissue changes | Ratio scale - higher values represent a better outcome | 6 months | 
| Patient perception outcomes | Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable' | 1 week and 6 months |