Immedaite vs Early Implant Placement in Aesthetic Area

N/AActive Not RecruitingNCT04653025

Vilniaus Implantologijos Centro (VIC) Klinika50 enrolled

Overview

The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.

Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Single Implant; Immediate Implant Treatment; Early Implant Treatment

Interventions

Implant placementDEVICE

After tooth extraction implants were placed either immediate or delayed approach

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. no recession of gingival contour of tooth to be extracted, 2. no periodontal bone loss of neighboring anterior teeth, 3. no implants in neighboring teeth, 4. class I extraction socket (intact buccal wall), 5. atraumatic extraction of the tooth with intact socket walls remaining, 6. only one implant per patient to be inserted. Exclusion Criteria: 1. deep bite (severe II class), 2. systemic disease (diabetes, osteoporosis), 3. heavy smokers (more than 10 cigarettes/day) were excluded. 4. atraumatic extraction of the tooth failed, 5. the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.

Locations (1)

VIC clinic

Vilnius, Lithuania

Outcomes

Primary Outcomes

Changes of pink aesthetic score (PES) over time

pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos.

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

Secondary Outcomes

Changes of marginal bone level (MBL) around implant neck

Periapical x-rays will be used to measure crestal bone sability distally and mesially of dental implant using certificated x-ray program after calibration. Measurement will be recorded in millimetres from implant neck to the first bone to implant contact

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

Recession changes of gingiva of restored tooth on the implant

Mid-buccal recession evaluation will be performed using standardised periodontal probe. Measurement of the crown hight will be done in the middle of the tooth from incisal edge to the highest point and recorded in millimetres.

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

Data from ClinicalTrials.gov

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