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

Not Applicable

Completed

• Conditions: Patient Satisfaction

• Registration Number: NCT06702969
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2022-06-15
• Status Verified: 2023-01
• Primary Completion: 2024-03-25
• Study Completion: 2024-05-16
• Study First Submitted: 2024-11-03
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pink esthetic 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	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
marginal bone loss	immediately after crown placement (baseline), then three months after crown placement	described by millimeter using paralleling technique

Secondary Outcome Measures

Name	Time	Method
patient satisfaction	after crown placement	satisfaction 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 index	Immediately after crown placement (baseline), one months later , and finally three months after crown placement	0 = 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 index	Immediately after crown placement (baseline), one months later , and finally three months after crown placement	0 = 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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt