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Clinical Efficacy of the Immediate Implant Loading

D

Damascus University

Status

Completed

Conditions

Implant Site Reaction

Treatments

Procedure: Indirect Provisional technique
Procedure: Direct provisional technique

Study type

Interventional

Funder types

Other

Identifiers

NCT03305679
UDDS-FixPro-01-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

Direct provisional technique
Experimental group
Description:
Patients here will be subjected to the direct provisional technique
Treatment:
Procedure: Direct provisional technique
Indirect Provisional technique
Active Comparator group
Description:
Patients here will be subjected to the indirect provisional technique
Treatment:
Procedure: Indirect Provisional technique

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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