Clinical Efficacy of the Immediate Implant Loading

NCT ID: NCT03305679

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-19

Study Completion Date

2018-07-19

Brief Summary

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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

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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.

Conditions

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Implant Site Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Direct provisional technique

Patients here will be subjected to the direct provisional technique

Group Type EXPERIMENTAL

Direct provisional technique

Intervention Type PROCEDURE

The method of implantation will be accomplished directly.

Indirect Provisional technique

Patients here will be subjected to the indirect provisional technique

Group Type ACTIVE_COMPARATOR

Indirect Provisional technique

Intervention Type PROCEDURE

The method of implantation will be accomplished indirectly.

Interventions

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Direct provisional technique

The method of implantation will be accomplished directly.

Intervention Type PROCEDURE

Indirect Provisional technique

The method of implantation will be accomplished indirectly.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St Joseph University, Beirut, Lebanon

OTHER

Sponsor Role collaborator

Syrian Atomic Energy Agency, Damascus, Syria

UNKNOWN

Sponsor Role collaborator

Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anas Abdo, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student in Fixed Prosthodontics, Department of Fixed Prosthodontics, University of Damascus Dental School

Osama Yousuf Solieman, DDS MSc PhD

Role: STUDY_DIRECTOR

Laboratoire Bioinge Ânierie et Nanosciences EA4203, Montpellier University, Montpellier, France

Christian Makary, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Oral Implantology, Sante Jousef University, School of Dental Medicine, Beirut, Lebanon

Mirza Allaf, DDS MSc PhD

Role: STUDY_CHAIR

Professor of Fixed Prosthodontics, University of Damascus Dental School, Damascus, Syria

Locations

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Department of Oral Implantology -Sante Jousef University - School of Dental Medicine

Beirut, , Lebanon

Site Status

Department of Fixed Prosthodontics, University of Damsacus

Damascus, , Syria

Site Status

Nano Physical lab and biomaterial Lab - College of Applied Sciences

Damascus, , Syria

Site Status

Countries

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Lebanon Syria

References

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

Reference Type BACKGROUND
PMID: 27314117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27596682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27501953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27902498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28351528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26100929 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25274041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26177118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24641774 (View on PubMed)

Other Identifiers

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UDDS-FixPro-01-2017

Identifier Type: -

Identifier Source: org_study_id

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