Clinical Efficacy of the Immediate Implant Loading
- Conditions
- Implant Site Reaction
- Interventions
- Procedure: Indirect Provisional techniqueProcedure: Direct provisional technique
- Registration Number
- NCT03305679
- Lead Sponsor
- Damascus University
- Brief Summary
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools.
Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
- Detailed Description
Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).
Materials and methods:
20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.
The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study.
Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- esthetic request.
- either incisor or canine indicated for extraction.
- symmetrical gingival level.
- no active periodontal disease.
- age between 20-40 years old
- Lateral hopeless tooth .
- Active periodontal lesion .
- loss of periodontal tissue .
- missed incisor or missed canine in the area of implantation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indirect Provisional technique Indirect Provisional technique Patients here will be subjected to the indirect provisional technique Direct provisional technique Direct provisional technique Patients here will be subjected to the direct provisional technique
- Primary Outcome Measures
Name Time Method Change in the Plaque Index T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation This will be measured using the the plaque index
Change in the Gingival Index T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation This will be measured using the the gingival index
Change in alveolar bone level T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation This will be measured using cone-beam computed tomography images
Change in Esthetic Appearance T1: at one day before implantation, T2: at three months following implantation This will be measured by using the White Esthetic Scale (WES)
Change in the Pink Esthetic Scale T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation This will be measured using the Pink Esthetic Scale
- Secondary Outcome Measures
Name Time Method Change in Restoration Color T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation This will be measured using a standardized color guide
Trial Locations
- Locations (3)
Department of Oral Implantology -Sante Jousef University - School of Dental Medicine
🇱🇧Beirut, Lebanon
Department of Fixed Prosthodontics, University of Damsacus
🇸🇾Damascus, Syrian Arab Republic
Nano Physical lab and biomaterial Lab - College of Applied Sciences
🇸🇾Damascus, Syrian Arab Republic