Immedaite vs Early Implant Placement in Aesthetic Area

Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Single Implant; Immediate Implant Treatment; Early Implant Treatment
• Intervention / Treatment: Device: Implant placement

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 10205
    • VIC Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Test group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting	Device: Implant placement; After tooth extraction implants were placed either immediate or delayed approach
Experimental: Control group; Patients in the control group received soft tissue grafting after tooth extraction and an implant with bone augmentation after 6 weeks of healing.	Device: Implant placement; After tooth extraction implants were placed either immediate or delayed approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 year and 5 years after prosthetic delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 1 year and 5 years after prosthetic delivery

Collaborators and Investigators

• Sponsor: Vilniaus Implantologijos Centro (VIC) Klinika
• Collaborators: Institut Straumann AG

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): January 10, 2020
• Study Completion (Anticipated): January 10, 2030

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 26, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IIS0816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No