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Trial record 14 of 92 for:    Recruiting, Not yet recruiting, Available Studies | "Jaw Diseases"

Esthetic and Radiographic Outcomes Following Immediate Implant Placement With or Without Labial Plate Defects

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ClinicalTrials.gov Identifier: NCT03319758
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Baoxin Huang, Sun Yat-sen University

Brief Summary:
The objective of this prospective clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with or without labial plate dehiscence defects using bone augmentation in combination with an absorbable collagen membrane.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Acquired Absence of Single Tooth Other: Intact labial plate Other: Compromised labial plate Not Applicable

Detailed Description:
The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with or without labial plate dehiscence defects using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. Thirty patients are recruited. They are divided into two groups: intact labial plate and compromised labial plate. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With or Without Labial Plate Defects in the Anterior Maxilla
Actual Study Start Date : May 2016
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2027

Arm Intervention/treatment
Experimental: Intact labial plate
Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane without labial plate dehiscence defects.
Other: Intact labial plate
Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. Thirty patients are recruited. They are divided into two groups: intact labial plate and compromised labial plate.

Experimental: Compromised labial plate.
Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with labial plate dehiscence defects.
Other: Compromised labial plate
Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. Thirty patients are recruited. They are divided into two groups: intact labial plate and compromised labial plate.




Primary Outcome Measures :
  1. Change of Pink and white esthetic scores (PES/WES) [ Time Frame: Change from baseline up to 10 years after implantation ]
    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.


Secondary Outcome Measures :
  1. Radiographic bone volume [ Time Frame: Up to 10 years after baseline ]
    Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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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): NCT03319758


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

Locations
China, Guangdong
Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Baoxin Huang, PhD    +8615820219260    dentisthbx@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Baoxin Huang, PhD Sun Yat-sen University

Publications of Results:
Responsible Party: Baoxin Huang, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03319758     History of Changes
Other Study ID Numbers: Baoxin Huang
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 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 Baoxin Huang, Sun Yat-sen University:
bone augmentation
esthetics
immediate implant
buccal bone defects

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