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

Ain Shams University14 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Patient Satisfaction

Interventions

Intra oral scannerDEVICE

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

impression analogDEVICE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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). -

Locations (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

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

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

marginal bone loss

described by millimeter using paralleling technique

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

Secondary Outcomes

patient satisfaction

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

Time frame: after crown placement

plaque index

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.

Data from ClinicalTrials.gov

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