Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

NCT ID: NCT02814149

Last Updated: 2019-11-01

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2027-06-30

Brief Summary

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The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

Detailed Description

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Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.

Conditions

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Jaw, Edentulous, Partially Acquired Absence of Single Tooth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Type 1 implant placement

Implant is placed immediately following tooth extraction in one surgical procedure

Group Type ACTIVE_COMPARATOR

Type 1 implant placement

Intervention Type PROCEDURE

Implant is placed immediately following tooth extraction in one surgical procedure

Type 3 implant placement

Implant is placed in the site which is left to heal for 3 months following tooth extraction

Group Type ACTIVE_COMPARATOR

Type 3 implant placement

Intervention Type PROCEDURE

Implant is placed in the site which is left to heal for 3 months following tooth extraction

Interventions

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Type 1 implant placement

Implant is placed immediately following tooth extraction in one surgical procedure

Intervention Type PROCEDURE

Type 3 implant placement

Implant is placed in the site which is left to heal for 3 months following tooth extraction

Intervention Type PROCEDURE

Other Intervention Names

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Immediate implant placement Delayed implant placement

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old and able to understand an informed consent
* Adequate oral hygiene to allow for implant therapy consistent with standards of care.
* Missing a single tooth in the maxillary anterior region
* Presence of adjacent natural teeth

Exclusion Criteria

* Poor oral hygiene
* Severe parafunctional habits, for example, bruxing and clenching
* Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
* Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
* Pregnant or expecting to be pregnant
* History of drug and alcohol abuse
* History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level \>7%)
* Radiotherapy in the head and neck area,
* On certain medications like bisphosphonates or steroids currently or within the past three months
* Absence of adjacent teeth
* Unwillingness to return for the follow-up examination
* Smokers (more than 20 cigarettes per day). Subjects smoking \<20 cigarettes per day were requested to stop smoking before and after surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xin Liu

post graduate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuofan Chen

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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Guanghua School of Stomatology Hospital of Stomatology

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Liu

Role: CONTACT

+8615902064014

Baoxin Huang

Role: CONTACT

+8615820219260

Facility Contacts

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Xin Liu

Role: primary

+8615902064014

Baoxin Huang

Role: backup

+8615820219260

References

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Rieder D, Eggert J, Krafft T, Weber HP, Wichmann MG, Heckmann SM. Impact of placement and restoration timing on single-implant esthetic outcome - a randomized clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):e80-6. doi: 10.1111/clr.12539. Epub 2014 Dec 12.

Reference Type BACKGROUND
PMID: 25496243 (View on PubMed)

Huynh-Ba G, Meister DJ, Hoders AB, Mealey BL, Mills MP, Oates TW, Cochran DL, Prihoda TJ, McMahan CA. Esthetic, clinical and patient-centered outcomes of immediately placed implants (Type 1) and early placed implants (Type 2): preliminary 3-month results of an ongoing randomized controlled clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):241-52. doi: 10.1111/clr.12577. Epub 2015 Mar 10.

Reference Type BACKGROUND
PMID: 25758100 (View on PubMed)

Other Identifiers

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XinL

Identifier Type: -

Identifier Source: org_study_id

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