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Clinical Trials/NCT02814149
NCT02814149
Recruiting
Not Applicable

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

Sun Yat-sen University1 site in 1 country40 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Jaw, Edentulous, Partially
Sponsor
Sun Yat-sen University
Enrollment
40
Locations
1
Primary Endpoint
Pink and white esthetic scores (PES/WES)
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
June 2027
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Xin Liu

post graduate

Sun Yat-sen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Implant survival(Up to 10 years after baseline)
  • Modified bleeding index(Up to 10 years after baseline)
  • Buccal marginal recession(Up to 10 years after baseline)
  • Papilla volume(Up to 10 years after baseline)
  • Probing depth(Up to 10 years after baseline)
  • Modified plaque index(Up to 10 years after baseline)
  • Width of keratinized gingiva(Up to 10 years after baseline)
  • Visual analogue scale (VAS)(Up to 10 years after baseline)
  • Oral health impact profile shortened version (OHIP-I)(Up to 10 years after baseline)

Study Sites (1)

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