Back to resultsImmediate Implant Placement With Connective Tissue Graft or Socket Shield
Primary Purpose
Tooth Fractures
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Connective tissue graft
socket shield technique
Immediate implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Fractures focused on measuring immediate implant placement, connective tissue graft, samll dehiscence
Eligibility Criteria
Inclusion Criteria:
- Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （<2mm vertical bone loss and <5mm horizontal bone loss） Patients with natural teeth adjacent to implant site
Exclusion Criteria:
- Uncontrolled periodontal diseases Heavy smokers (>10 cigarettes/day) Unwilling to participate in the present study
Sites / Locations
- Shanghai Ninth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Test Group
Arm Description
Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished.
Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished.
Outcomes
Primary Outcome Measures
pink esthetic score （PES）
An objective index introduced by Furhauser et al. 2005
Secondary Outcome Measures
mucosal recession
the mid-buccal mucosal level change from baseline to follow-up
marginal bone loss
the mesial and dital marginal bone loss from baseline to follow-up evaluated by peri-apical X-ray.
pocket probing depth
the pocket depth at six sites around implant will be detected by periodontal probe
bleeding on probing
the percentage of bleeding after probing by periodontal probe
Full Information
NCT ID
NCT03594019
First Posted
July 11, 2018
Last Updated
May 14, 2019
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT03594019
Brief Title
Immediate Implant Placement With Connective Tissue Graft or Socket Shield
Official Title
Immediate Implant Placement Without Connective Tissue Graft or Socket Shield: a Randomized Controlled Clincial Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present study aims to evaluate the clinical outcomes of immediate implant placement with connective tissue graft or socket shield. Previous studies have demonstrate the intact buccal bone plate plays an important role in the stability of peri-implant soft tissue around immediately placed implants. However, it remains controverisal whether soft tissue stability could be achieved in immediate implant placement with connective tissue graft or socket shield.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fractures
Keywords
immediate implant placement, connective tissue graft, samll dehiscence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients in the control group will follow the conventional treatment protocol combined with connective tissue graft. Briefly, hopeless tooth will be extracted atraumatically. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. Then, connective tissue graft will be harvest from palatal and fixed between bucall mocosa and bucall bone. Healing abutment will placed and collegan sponge will be used to seal the wound. After 4 months, implant impression and crown delivery will be finished.
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Patients in the test group will receive conventional immediate implant placement combined with socket shield technique. Briefly, the hopeless teeth will be splited from mesial and distal, the buccal part will be preseved and the palatal part will extracted. Implant will be placed in the palatal side and grafting materials will be filled in the buccal gap. After 4 months, implant impression and crown delivery will be finished.
Intervention Type
Procedure
Intervention Name(s)
Connective tissue graft
Intervention Description
Connective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites.
Intervention Type
Procedure
Intervention Name(s)
socket shield technique
Intervention Description
The procedure is used to split the teeth and preserve the buccal part
Intervention Type
Procedure
Intervention Name(s)
Immediate implant placement
Intervention Description
The implant will be placed in the frest socket immediately after tooth extraction
Primary Outcome Measure Information:
Title
pink esthetic score （PES）
Description
An objective index introduced by Furhauser et al. 2005
Time Frame
1 year
Secondary Outcome Measure Information:
Title
mucosal recession
Description
the mid-buccal mucosal level change from baseline to follow-up
Time Frame
1 year
Title
marginal bone loss
Description
the mesial and dital marginal bone loss from baseline to follow-up evaluated by peri-apical X-ray.
Time Frame
1 year
Title
pocket probing depth
Description
the pocket depth at six sites around implant will be detected by periodontal probe
Time Frame
1 year
Title
bleeding on probing
Description
the percentage of bleeding after probing by periodontal probe
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in need of single implant treatment in anterior maxilla Patients with small dehiscence in the buccal bone plate （<2mm vertical bone loss and <5mm horizontal bone loss） Patients with natural teeth adjacent to implant site
Exclusion Criteria:
Uncontrolled periodontal diseases Heavy smokers (>10 cigarettes/day) Unwilling to participate in the present study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junyu Shi, PhD
Phone
081 53315299
Email
sakyamuni_jin@163.com
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyu Shi, MDS
Phone
081-53315299
Email
sakyamuni_jin@163.com
12. IPD Sharing Statement
Learn more about this trial
Immediate Implant Placement With Connective Tissue Graft or Socket Shield
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