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NCT Number: NCT06702969

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

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

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Key information

Conditions

Patient Satisfaction Behavior Health Behavior Treatment Adherence and Compliance

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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). -

Treatment and study plan

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

Other names: implant placement

impression analog

Device

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

Primary outcomes

  1. pink esthetic score

    Time frame: 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

    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

  2. marginal bone loss

    Time frame: immediately after crown placement (baseline), then three months after crown placement

    described by millimeter using paralleling technique

Secondary outcomes

  1. patient satisfaction

    Time frame: after crown placement

    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

  2. plaque index

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

    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.

  3. gingival index

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

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 25, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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