Clinical trial NCT03305679: Clinical Efficacy of the Immediate Implant Loading
Official title: Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Lead sponsor: Damascus University
Sponsor class: OTHER
Collaborators: name: St Joseph University, Beirut, Lebanon
name: Syrian Atomic Energy Agency, Damascus, Syria
First posted: 2017-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. esthetic request.
2. either incisor or canine indicated for extraction.
3. symmetrical gingival level.
4. no active periodontal disease.
5. age between 20-40 years old

Exclusion Criteria:

1. Lateral hopeless tooth .
2. Active periodontal lesion .
3. loss of periodontal tissue .
4. missed incisor or missed canine in the area of implantation.

Primary outcomes:
measure: Change in alveolar bone level
timeFrame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
measure: Change in the Gingival Index
timeFrame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
measure: Change in Esthetic Appearance
timeFrame: T1: at one day before implantation, T2: at three months following implantation
measure: Change in the Plaque Index
timeFrame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
measure: Change in the Pink Esthetic Scale
timeFrame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Secondary outcomes:
measure: Change in Restoration Color
timeFrame: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Department of Oral Implantology -Sante Jousef University - School of Dental Medicine
city: Damascus
country: Syrian Arab Republic
facility: Department of Fixed Prosthodontics, University of Damsacus
city: Damascus
country: Syrian Arab Republic
facility: Nano Physical lab and biomaterial Lab - College of Applied Sciences
Study officials:
affiliation: PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School
name: Anas Abdo, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France
name: Osama Yousuf Solieman, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon
name: Christian Makary, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria
name: Mirza Allaf, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34.
citation: Sanchez-Siles M, Munoz-Camara D, Salazar-Sanchez N, Camacho-Alonso F, Calvo-Guirado JL. Crestal bone loss around submerged and non-submerged implants during the osseointegration phase with different healing abutment designs: a randomized prospective clinical study. Clin Oral Implants Res. 2018 Jul;29(7):808-812. doi: 10.1111/clr.12981. Epub 2016 Sep 5.
citation: Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
citation: Sethi A, Kaus T. Immediate Replacement of Single Teeth With Immediately Loaded Implants: Retrospective Analysis of a Clinical Case Series. Implant Dent. 2017 Feb;26(1):30-36. doi: 10.1097/ID.0000000000000512.
citation: Zhang S, Wang S, Song Y. Immediate loading for implant restoration compared with early or conventional loading: A meta-analysis. J Craniomaxillofac Surg. 2017 Jun;45(6):793-803. doi: 10.1016/j.jcms.2016.05.002. Epub 2016 May 14.
citation: Abdel-Azim T, Rogers K, Elathamna E, Zandinejad A, Metz M, Morton D. Comparison of the marginal fit of lithium disilicate crowns fabricated with CAD/CAM technology by using conventional impressions and two intraoral digital scanners. J Prosthet Dent. 2015 Oct;114(4):554-9. doi: 10.1016/j.prosdent.2015.04.001. Epub 2015 Jun 20.
citation: Varol S, Kulak-Ozkan Y. In Vitro Comparison of Marginal and Internal Fit of Press-on-Metal Ceramic (PoM) Restorations with Zirconium-Supported and Conventional Metal Ceramic Fixed Partial Dentures Before and After Veneering. J Prosthodont. 2015 Jul;24(5):387-93. doi: 10.1111/jopr.12229. Epub 2014 Oct 1.
citation: Renne W, Wolf B, Kessler R, McPherson K, Mennito AS. Evaluation of the Marginal Fit of CAD/CAM Crowns Fabricated Using Two Different Chairside CAD/CAM Systems on Preparations of Varying Quality. J Esthet Restor Dent. 2015 Jul-Aug;27(4):194-202. doi: 10.1111/jerd.12148. Epub 2015 Jul 14.
citation: Louropoulou A, Slot DE, Van der Weijden F. Influence of mechanical instruments on the biocompatibility of titanium dental implants surfaces: a systematic review. Clin Oral Implants Res. 2015 Jul;26(7):841-50. doi: 10.1111/clr.12365. Epub 2014 Mar 19.