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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06702969
Enrollment
14
Registered
2024-11-25
Start date
2022-06-15
Completion date
2024-05-16
Last updated
2025-09-25

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

Conditions

Patient Satisfaction

Keywords

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

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. 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

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.

Interventions

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

DEVICEimpression analog

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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). -

Design outcomes

Primary

MeasureTime frameDescription
pink esthetic scoreat 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 placementThe 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
marginal bone lossimmediately after crown placement (baseline), then three months after crown placementdescribed by millimeter using paralleling technique

Secondary

MeasureTime frameDescription
patient satisfactionafter crown placementsatisfaction questionnaire modified from based on 10 specific questions. The questions were as follows: 1. Are you satisfied with the treatment? with 0 = very dissatisfied and 100 = very satisfied 2. Did you experience discomfort during the impression-taking? with 0 = high discomfort and 100 = no discomfort 3. Did you experience gag reflex/nausea during the impression-taking? with 0 = strong gag reflex/nausea, and 100 = no gag reflex/nausea 4. How comfortable was the impression procedure? with 0 = uncomfortable and 100 = comfortable 5. Does your implant-supported restoration function well? with 0 = bad function and 100 = well function
plaque indexImmediately after crown placement (baseline), one months later , and finally three months after crown placement0 = No plaque in gingival area. 1. = 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. 2. = 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. 3. = 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.
gingival indexImmediately after crown placement (baseline), one months later , and finally three months after crown placement0 = Normal gingiva. 1. = Mild inflammation, slight change in color, slight edema; no bleeding on probing. 2. = Moderate inflammation, redness, edema, and glazing; bleeding on probing. 3. = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.

Countries

Egypt

Outcome results

None listed

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