Clinical Efficacy of the Immediate Implant Loading

Implant Site Reaction Clinical Trial

Official title:

Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305679
• Other study ID #: UDDS-FixPro-01-2017
• Status: Completed
• Phase: N/A
• Start date: January 19, 2017
• Est. completion date: July 19, 2018

Study information

• Verified date: July 2018
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 19, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Implant Site Reaction

Intervention

Procedure:
• Direct provisional technique
The method of implantation will be accomplished directly.
• Indirect Provisional technique
The method of implantation will be accomplished indirectly.

Locations

Country	Name	City	State
Lebanon	Department of Oral Implantology -Sante Jousef University - School of Dental Medicine	Beirut
Syrian Arab Republic	Department of Fixed Prosthodontics, University of Damsacus	Damascus
Syrian Arab Republic	Nano Physical lab and biomaterial Lab - College of Applied Sciences	Damascus

Sponsors (3)

Lead Sponsor	Collaborator
Damascus University	St Joseph University, Beirut, Lebanon, Syrian Atomic Energy Agency, Damascus, Syria

Countries where clinical trial is conducted

Lebanon,  Syrian Arab Republic, 

References & Publications (9)

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. — View Citation

Friberg B. Bone augmentation for single tooth implants: A review of the literature. Eur J Oral Implantol. 2016;9 Suppl 1:S123-34. Review. — View 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. Review. — View 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. — View Citation

Sánchez-Siles M, Muñoz-Cámara D, Salazar-Sánchez 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. 2016 Sep 5. doi: 10.1111/clr.12981. [Epub ahead of print] — View 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. — View 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. — View Citation

Varol S, Kulak-Özkan 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alveolar bone level	This will be measured using cone-beam computed tomography images	T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation
Primary	Change in the Gingival Index	This will be measured using the 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
Primary	Change in Esthetic Appearance	This will be measured by using the White Esthetic Scale (WES)	T1: at one day before implantation, T2: at three months following implantation
Primary	Change in the Plaque Index	This will be measured using the 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
Primary	Change in the Pink Esthetic Scale	This will be measured using 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
Secondary	Change in Restoration Color	This will be measured using a standardized color guide	T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation