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

Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Device: Intra oral scanner; Device: impression analog

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11566
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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). -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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; Other Names: implant placement
Active Comparator: 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	Device: impression analog; Immediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression; Other Names: implant placement; impression copying

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	satisfaction questionnaire modified from based on 10 specific questions. The questions were as follows: Are you satisfied with the treatment? with 0 = very dissatisfied and 100 = very satisfied; Did you experience discomfort during the impression-taking? with 0 = high discomfort and 100 = no discomfort; Did you experience gag reflex/nausea during the impression-taking? with 0 = strong gag reflex/nausea, and 100 = no gag reflex/nausea; How comfortable was the impression procedure? with 0 = uncomfortable and 100 = comfortable; Does your implant-supported restoration function well? with 0 = bad function and 100 = well function	after crown placement
plaque index	0 = No plaque in gingival area.; = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface.; = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye.; = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.of sites positive for dental plaque will be calculated for each case.	Immediately after crown placement (baseline), one months later , and finally three months after crown placement
gingival index	0 = Normal gingiva.; = Mild inflammation, slight change in color, slight edema; no bleeding on probing.; = Moderate inflammation, redness, edema, and glazing; bleeding on probing.; = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.	Immediately after crown placement (baseline), one months later , and finally three months after crown placement

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: ola A ezzat, professsor, Faculty of Dentistry-Ain shams university

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 20, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Conventional impression; Immediate implant; Digital impression; Pink esthetic score
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction
• Other Study ID Numbers: Digitalized Impression

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No