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

October 31, 2019 updated by: Xin Liu, Sun Yat-sen University

Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guanghua School of Stomatology Hospital of Stomatology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
Procedure: Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
Other Names:
  • Immediate implant placement
Active Comparator: Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Procedure: Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Other Names:
  • Delayed implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink and white esthetic scores (PES/WES)
Time Frame: Up to 10 years after baseline
Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Radiographic bone volume
Time Frame: Up to 10 years after baseline
Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: Up to 10 years after baseline
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Probing depth
Time Frame: Up to 10 years after baseline
Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Modified plaque index
Time Frame: Up to 10 years after baseline
Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Modified bleeding index
Time Frame: Up to 10 years after baseline
Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Buccal marginal recession
Time Frame: Up to 10 years after baseline
Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Papilla volume
Time Frame: Up to 10 years after baseline
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Width of keratinized gingiva
Time Frame: Up to 10 years after baseline
Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Visual analogue scale (VAS)
Time Frame: Up to 10 years after baseline
A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline
Oral health impact profile shortened version (OHIP-I)
Time Frame: Up to 10 years after baseline
A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Up to 10 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Zhuofan Chen, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XinL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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