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

NCT06702969 | Completed

• 1 other identifier: Digitalized Impression
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Satisfaction

Keywords

Immediate implant; Digital impression; Pink esthetic score; Conventional impression

Outcome Measures

Primary Outcomes (2)

• pink esthetic score

  The pink esthetic score is based on seven variables: * Mesial papilla * Distal papilla * Soft-tissue level * Soft- tissue contour * Alveolar process deficiency * Soft-tissue color and texture Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score

  at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement

• marginal bone loss

  described by millimeter using paralleling technique

  immediately after crown placement (baseline), then three months after crown placement

Secondary Outcomes (3)

• patient satisfaction

  after crown placement

• plaque index

  Immediately after crown placement (baseline), one months later , and finally three months after crown placement

• gingival index

  Immediately after crown placement (baseline), one months later , and finally three months after crown placement

Study Arms (2)

Digital impression with intraoral scanner

ACTIVE COMPARATOR

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.

Device: Intra oral scanner

conventional impression technique

ACTIVE COMPARATOR

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

Device: impression analog

Interventions

Intra oral scanner DEVICE

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

Also known as: implant placement

Digital impression with intraoral scanner

impression analog DEVICE

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

Also known as: implant placement, impression copying

conventional impression technique

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Missing adjacent teeth or opposing tooth. .
• Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.
• Smokers.
• Pregnant or lactating females.
• Patients with para-functional habits (bruxism and/or clenching)
• Vulnerable groups (handicapped, orphans, and prisoners). -

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• ola A ezzat, professsor

  faculty of dentistry-Ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 25, 2024
• Study Start: June 15, 2022
• Primary Completion: March 25, 2024
• Study Completion: May 16, 2024
• Last Updated: September 25, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)