Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile

NCT ID: NCT06702969

Last Updated: 2025-09-25

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-05-16

Brief Summary

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This randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing:

1. pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives
2. Patients' satisfaction and clinical outcomes as secondary objectives

Detailed Description

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fourteen patients with single nonrestorable tooth in the esthetic zone participated in the study and were replaced with immediate implants with immediate customized provisional restoration after 3 months they recalled for the impression, seven with digital and the others with conventional and evaluated.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Digital impression with intraoral scanner

included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with full digital procedure consisting of digital impression with intraoral scanner, and Computer Aided Design/ Computer Aided Manufacture (CAD/CAM) procedure.

Group Type ACTIVE_COMPARATOR

Intra oral scanner

Intervention Type DEVICE

Immediate implant placement with customized healing abutment and after three months placement all ceramic crown by digital impression using intra oral scanner

conventional impression technique

included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with Conventional impression-taking with polyvinyl siloxane, plaster model pouring and lost-wax casting technique

Group Type ACTIVE_COMPARATOR

impression analog

Intervention Type DEVICE

Immediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression

Interventions

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Intra oral scanner

Immediate implant placement with customized healing abutment and after three months placement all ceramic crown by digital impression using intra oral scanner

Intervention Type DEVICE

impression analog

Immediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression

Intervention Type DEVICE

Other Intervention Names

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implant placement implant placement impression copying

Eligibility Criteria

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Inclusion Criteria

1. Both genders within age range of 20-50 years.
2. Systemically healthy participants classified as American Society of Anesthesiologists( ASA ) class I . Guided by medical questionnaire modified from Burkett's
3. Single non restorable tooth in upper anterior esthetic zone with at least 4 mm bone present apical to the root apex for primary stability.
4. Type I extraction sockets according to classification.
5. Ability to attend the surgery , comply to it's procedures , the recall visits and oral hygiene protocol .
6. Thick gingival phenotype with thickness ≥ 2 mm around the non-restorable tooth -

Exclusion Criteria

1. Missing adjacent teeth or opposing tooth. .
2. Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.
3. Smokers.
4. Pregnant or lactating females.
5. Patients with para-functional habits (bruxism and/or clenching)
6. Vulnerable groups (handicapped, orphans, and prisoners). -
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ola A ezzat, professsor

Role: STUDY_DIRECTOR

faculty of dentistry-Ain shams university

Locations

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Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Digitalized Impression

Identifier Type: -

Identifier Source: org_study_id

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