Clinical trial NCT04653025: Immedaite vs Early Implant Placement in Aesthetic Area
Official title: Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Single Implant; Immediate Implant Treatment; Early Implant Treatment
Lead sponsor: Vilniaus Implantologijos Centro (VIC) Klinika
Sponsor class: NETWORK
Collaborators: name: Institut Straumann AG
First posted: 2020-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of pink aesthetic score (PES) over time
timeFrame: Baseline, 1 year and 5 years after prosthetic delivery
Secondary outcomes:
measure: Changes of marginal bone level (MBL) around implant neck
timeFrame: Baseline, 1 year and 5 years after prosthetic delivery
measure: Recession changes of gingiva of restored tooth on the implant
timeFrame: Baseline, 1 year and 5 years after prosthetic delivery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: VIC clinic
Study officials:
References: