Comparing the esthetic results and efficiency of 2 treatment protocols: the conventional approach using provisional crowns to sculpt the soft tissue before fabrication of the final crown, and a faster protocol, in which the final crown is finished directly without provisional crown phase.
- Conditions
- Missing single toothOral Health
- Registration Number
- ISRCTN98697476
- Lead Sponsor
- Oral Reconstruction Fundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1. Older 22 years old
2. Patients with Conelog Implants placed in the anterior and premolar region in the maxilla or mandible.
3. These implants should:
3.1. Allow for a screw retained reconstruction
3.2. Be submerged (second stage surgery is the 1st study appointment)
4. Two neighboring teeth are present, or one tooth and one implant
5. Capable of providing written informed consent
6. Obtained informed consent from the patient
7. 2mm band of keratinized mucosa at implant site
8. Patients with adequate oral hygiene Plaque Index < 20% or persistent intraoral infection BoP < 20%
1. Medical condition that contraindicates surgery: ASA -score = III
2. History of radiotherapy in the head and neck region
3. History of bisphosphonate medication
4. Women of childbearing potential with a positive urine pregnancy test
5. Medium smokers = 10 cigarettes per day
6. Patients unwilling or incapable of understanding and signing the informed consent
7. Pronounced esthetic expectations
8. Severe bruxism or clenching habits
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Esthetic outcome is measured using the PES/WES”: which is an esthetic index described by Belser in 2009 which is done by taking photographs (the photographs are examined and given points to different parameter, such as papilla fill, texture of soft tissue, volume, or color of soft tissue) at each follow up appointment<br>2. Volumetric changes is measured using digital models of the site of interest through the intraoral impression system
- Secondary Outcome Measures
Name Time Method 1. Biologic soft tissue outcomes is measured by registering the PPD (periodontal pocket depth), bleeding, and plaque around the implant crown at the follow up visit, which we would do anyway in routine control visits after crown placement<br>2. Biologic hard tissue outcomes is measured by registering the bone level changes: a small periapical radiograph is taken to evaluate bone level changes around the implant crown at the follow up visit<br>3. Efficiency comparison of the 2 protocols measured registering the time it takes in each procedure, and adding the time for all the procedures in the same protocol group. After, once the esthetic outcomes have been summed up, we may discus if the higher efforts of the control group was worth it.<br>