Clinical Efficacy of the Immediate Implant Loading

NCT03305679 | Completed DMC

• 1 other identifier: UDDS-FixPro-01-2017
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Implant Site Reaction

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• 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

Study Arms (2)

Direct provisional technique

EXPERIMENTAL

Patients here will be subjected to the direct provisional technique

Procedure: Direct provisional technique

Indirect Provisional technique

ACTIVE COMPARATOR

Patients here will be subjected to the indirect provisional technique

Procedure: Indirect Provisional technique

Interventions

Direct provisional technique PROCEDURE

The method of implantation will be accomplished directly.

Direct provisional technique

Indirect Provisional technique PROCEDURE

The method of implantation will be accomplished indirectly.

Indirect Provisional technique

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Lateral hopeless tooth .
• Active periodontal lesion .
• loss of periodontal tissue .
• missed incisor or missed canine in the area of implantation.

Sponsors & Collaborators

• Damascus University: lead
• St Joseph University, Beirut, Lebanon: collaborator
• Syrian Atomic Energy Agency, Damascus, Syria: collaborator

Study Sites (3)

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

Beirut, Lebanon

Location

Department of Fixed Prosthodontics, University of Damsacus

Damascus, DM20AM18, Syria

Location

Nano Physical lab and biomaterial Lab - College of Applied Sciences

Damascus, Syria

Location

Related Publications (9)

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

  PMID: 27314117 BACKGROUND

• 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.

  PMID: 27596682 BACKGROUND

• 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.

  PMID: 27501953 BACKGROUND

• 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.

  PMID: 27902498 BACKGROUND

• 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.

  PMID: 28351528 BACKGROUND

• 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.

  PMID: 26100929 BACKGROUND

• 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.

  PMID: 25274041 BACKGROUND

• 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.

  PMID: 26177118 BACKGROUND

• 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.

  PMID: 24641774 BACKGROUND

Study Officials

• Anas Abdo, DDS MSc

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

  PRINCIPAL INVESTIGATOR

• Osama Yousuf Solieman, DDS MSc PhD

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

  STUDY DIRECTOR

• Christian Makary, DDS MSc PhD

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

  STUDY DIRECTOR

• Mirza Allaf, DDS MSc PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 10, 2017
• Study Start: January 19, 2017
• Primary Completion: January 19, 2018
• Study Completion: July 19, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1); SY (2)