Comparison of Peri Implant Soft Tissue Esthetics With Immediate Temporization With and Without Subepithelial Connective Tissue Graft

Study Overview
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Brief Summary
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The aim of this study is to clinically evaluate peri-implant soft tissue esthetics around single delayed implants in the esthetic zone.

Detailed Description
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To compare the efficacy of soft tissue augmentation on the peri-implant soft tissue esthetics along with immediate temporization to immediate temporization only. Population (P): patients with a single missing tooth in the esthetic zone Intervention (I): Delayed implant placement with immediate temporization and subepithelial connective tissue graft Comparator (C): Delayed implant placement with immediate temporization Primary outcome: Pink esthetic score (PES) Time frame: 6 months Study design: Randomized controlled clinical trial

Official Title
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Comparison of Peri-implant Soft Tissue Esthetics Around Single Delayed Implant With Immediate Provisionalization Placed in The Esthetic Zone With and Without Using Subepithelial Connective Tissue Graft: A Randomized Clinical Trial

Conditions
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Immediate Temporization and Soft Tissue Augmentation Around Delayed Implants

Intervention / Treatment
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* Procedure: delayed implant with immediate provisionaliztion and soft tissue graft
* Procedure: delayed implant placement with immediate provisionalization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Good medical and psychological health Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients required periodontal treatment (non-surgical and/or surgical), this was arranged outside the study protocol and completed at least 30 days prior to the enrolment Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region Willingness to sign the informed consent form Exclusion Criteria: Any known disease (not including controlled diabetes mellitus), infections or recent surgical procedures within 30 days of study initiation; Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) within 1 month before baseline visit; Anticoagulant therapy with warfarin, clopidogrel, ticlopidine or once daily aspirin (more than 81 mg); HIV or Hepatitis; Physical handicaps that would interfere with the ability to perform adequate oral hygiene; Alcoholism or chronic drug abuse; Heavy smokers (>10/cigarettes per day); Lack of adequate primary stability at implant insertion that enables immediate provisionalization (insertion torque ca 30 Ncm).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: Delayed implant placement with immediate provisionalization<br>Single delayed implant placement in the esthetic zone with placing an immediate temporary crown placed within 48 hours after the surgery | Procedure: delayed implant with immediate provisionaliztion and soft tissue graft<br>* delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal<br>|
| Experimental: Implant with immediate temporization and soft tissue graft<br>Single delayed implant placement in the esthetic zone with placing a subepithelial connective tissue graft buccal to the implant and immediate temporary crown within 48 hours after the surgery | Procedure: delayed implant placement with immediate provisionalization<br>* delayed implant placement with immediate provisionalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink Esthetic Score | Pink esthetic score evaluates the soft tissue esthetics around implant supported crowns. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value. The maximum achievable PES is 14. 7 variables are measured: mesial and distal papillae being 0 if absent, 1 if incomplete and 2 if complete. Alveolar process, soft tissue level, contour, texture and color being 0 if major discrepancy, 1 if minor discrepancy and 2 if matches the contralateral | 3 months post definitive prosthesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction by Visual analogue scale (VAS) | Patient satisfaction will be evaluated using a questionnaire which is based on a visual analog scale (VAS). A horizontal VAS bar, 100 mm long, with the right anchor labeled much less than natural teeth which is marked by zero and the left anchor labeled much more which is marked by 10 will be used. Five questions will be formulated to record the patients' satisfaction in terms of functionality and from an esthetic point of view. Participants will look in a mirror and also be viewed a photograph before recording their answers on the horizontal calibrated line. | 3 months post definitive | 
| Buccal peri-implant soft tissue thickness | the soft tissue thickness buccal to the implant by using an anesthesia needle and digital caliper | 3 months post definitive | 
| Recession of the buccal peri-implant mucosa | measured at the apical zenith of the mucosal margin on the implants after digital superimposition of the optically scanned models as the vertical distance change between the former and the new position of soft tissue margins. | 3 months post definitive |