Immedaite vs Early Implant Placement in Aesthetic Area

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2030-01-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Single Implant; Immediate Implant Treatment; Early Implant Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test group

Test group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting

Group Type EXPERIMENTAL

Implant placement

Intervention Type DEVICE

After tooth extraction implants were placed either immediate or delayed approach

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.

Group Type EXPERIMENTAL

Implant placement

Intervention Type DEVICE

After tooth extraction implants were placed either immediate or delayed approach

Interventions

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Implant placement

After tooth extraction implants were placed either immediate or delayed approach

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes