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

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ClinicalTrials.gov Identifier: NCT02814149
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Xin Liu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Acquired Absence of Single Tooth Procedure: Type 1 implant placement Procedure: Type 3 implant placement Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : June 2027

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 Name: 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 Name: Delayed implant placement




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814149


Contacts
Contact: Xin Liu +8615902064014 838667172@163.com
Contact: Baoxin Huang +8615820219260 dentisthbx@163.com

Locations
China, Guangdong
Guanghua School of Stomatology Hospital of Stomatology Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xin Liu    +8615902064014    838667172@163.com   
Contact: Baoxin Huang    +8615820219260    dentisthbx@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Zhuofan Chen Sun Yat-sen University

Publications:
Responsible Party: Xin Liu, post graduate, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02814149     History of Changes
Other Study ID Numbers: XinL
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xin Liu, Sun Yat-sen University:
delayed implant
esthetics
immediate implant
bone augmentation

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases