Clinical trial NCT06702969: Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile
Official title: Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: Immediate implant
Digital impression
Pink esthetic score
Conventional impression
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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). -

Primary outcomes:
measure: pink esthetic score
timeFrame: 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
measure: marginal bone loss
timeFrame: immediately after crown placement (baseline), then three months after crown placement
Secondary outcomes:
measure: patient satisfaction
timeFrame: after crown placement
measure: plaque index
timeFrame: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
measure: gingival index
timeFrame: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: faculty of dentistry-Ain shams university
name: ola A ezzat, professsor
role: STUDY_DIRECTOR
References: