Immedaite vs Early Implant Placement in Aesthetic Area

Study Overview
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Brief Summary
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The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.

Detailed Description
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Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.

Official Title
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Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.

Conditions
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Single Implant; Immediate Implant Treatment; Early Implant Treatment

Intervention / Treatment
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* Device: Implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no recession of gingival contour of tooth to be extracted, no periodontal bone loss of neighboring anterior teeth, no implants in neighboring teeth, class I extraction socket (intact buccal wall), atraumatic extraction of the tooth with intact socket walls remaining, only one implant per patient to be inserted. Exclusion Criteria: deep bite (severe II class), systemic disease (diabetes, osteoporosis), heavy smokers (more than 10 cigarettes/day) were excluded. atraumatic extraction of the tooth failed, the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.

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
Interventional Model Description: Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Test group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting | Device: Implant placement<br>* After tooth extraction implants were placed either immediate or delayed approach<br>|
| Experimental: Control group<br>Patients in the control group received soft tissue grafting after tooth extraction and an implant with bone augmentation after 6 weeks of healing. | Device: Implant placement<br>* After tooth extraction implants were placed either immediate or delayed approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of pink aesthetic score (PES) over time | pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos. | Baseline, 1 year and 5 years after prosthetic delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of marginal bone level (MBL) around implant neck | Periapical x-rays will be used to measure crestal bone sability distally and mesially of dental implant using certificated x-ray program after calibration. Measurement will be recorded in millimetres from implant neck to the first bone to implant contact | Baseline, 1 year and 5 years after prosthetic delivery | 
| Recession changes of gingiva of restored tooth on the implant | Mid-buccal recession evaluation will be performed using standardised periodontal probe. Measurement of the crown hight will be done in the middle of the tooth from incisal edge to the highest point and recorded in millimetres. | Baseline, 1 year and 5 years after prosthetic delivery |