Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

Study Overview
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Brief Summary
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The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Detailed Description
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Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Official Title
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Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

Conditions
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Dental Implants, Single-Tooth

Intervention / Treatment
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* Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England)
* Other: Customized healing abutment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with: Adequate interarch and mesiodistal space. Proper bone height and width. Adequate zone of keratinized tissue (at least 2 mm) Exclusion Criteria: Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases A history of head and neck radiation treatment. Periodontal diseases. Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32) Parafunctional habits. Malocclusion.

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healing abutment with scan peg (Neoss implant system, Harrogate, England)<br>12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg | Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England)<br>* 12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg<br>|
| Active Comparator: Customized healing abutment<br>12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment | Other: Customized healing abutment<br>* 12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scanning time (healing abutment-scan peg vs scan body) | The scanning time by intraoral scanner will be recorded in both groups | Through study completion, an average of 1 year | 
| Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body | The proximal contacts will be evaluated with dental floss Open: an open contact will be reported if there is no resistance against floss Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion. Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point. The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later. | Through study completion, an average of 1 year | 
| Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body | An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ. No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment. Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment. Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major. Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported. The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later. | Through study completion, an average of 1 year | 
| Evaluation of occlusion by digital occlusal analyzer | occlusal force of implant-supported restorations will be measured | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant Probing Depth (scan peg vs customized healing abutment) | Peri-implant probing depth refers to the distance from the gingival margin till the point of least resistance. The peri-implant probing depth will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 4 sites around each implant; mesiobuccal, disto-buccal, mesio-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated. | up to 6 months | 
| Clinical Attachment level (scan peg vs customized healing abutment) | It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level will be performed simultaneously while measuring the peri-implant probing depth. | up to 6 months | 
| Modified gingival index (scan peg vs customized healing abutment) | The peri-implant mucosal tissues around the implants will be assessed according to Lobene and Weatherford. The category criteria for assessment will be as follows: 0: Absence of inflammation, normal gingiva. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized). Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized). Moderate inflammation, redness, and edema. Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant. | up to 6 months | 
| Marginal bone loss (scan peg vs customized healing abutment) | Periapical digital radiographs will be taken at time of crown insertion (baseline) and up to 6 months later. Changes in the marginal bone level will be evaluated every time using standardized radiographs. To achieve the same orthoradial perspective on the implants, X-ray film positioning devices will be used. After importing screenshots of the radiographs, the amount of bone loss will be measured. | up to 6 months |