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Clinical Efficacy of the Immediate Implant Loading

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03305679
Enrollment
20
Registered
2017-10-10
Start date
2017-01-19
Completion date
2018-07-19
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Site Reaction

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.

Interventions

PROCEDUREDirect provisional technique

The method of implantation will be accomplished directly.

PROCEDUREIndirect Provisional technique

The method of implantation will be accomplished indirectly.

Sponsors

St Joseph University, Beirut, Lebanon
CollaboratorOTHER
Syrian Atomic Energy Agency, Damascus, Syria
CollaboratorUNKNOWN
Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in alveolar bone levelT1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantationThis will be measured using cone-beam computed tomography images
Change in the Gingival IndexT1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantationThis will be measured using the the gingival index
Change in Esthetic AppearanceT1: at one day before implantation, T2: at three months following implantationThis will be measured by using the White Esthetic Scale (WES)
Change in the Plaque IndexT1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantationThis will be measured using the the plaque index
Change in the Pink Esthetic ScaleT1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantationThis will be measured using the Pink Esthetic Scale

Secondary

MeasureTime frameDescription
Change in Restoration ColorT1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantationThis will be measured using a standardized color guide

Countries

Lebanon, Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026