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Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

Primary Purpose

Jaw, Edentulous, Partially, Acquired Absence of Single Tooth

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
buccal bone augmentation
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring bone augmentation, esthetics, immediate implant, buccal bone defects

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The inclusion criteria were as follows:

  1. 18 to 70-year-old;
  2. Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
  3. Single maxillary anterior teeth (canine to canine);
  4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；
  5. Presence of adjacent nature tooth;
  6. Good compliance;
  7. No palatal vertical bone loss;
  8. Good oral hygiene.

Exclusion criteria are as follow:

  1. Uncontrolled periodontal or systemic disease;
  2. General psychiatric contraindications;
  3. More than 20 cigarettes per day;
  4. History of head and neck radiotherapy；
  5. Pregnant or expecting to be pregnant;
  6. Patients with local or generalized healing limitations;
  7. Bruxism or other destructive parafunctional habits;
  8. Drug abuse or alcohol abuse.

Sites / Locations

  • Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thin or dehiscences buccal plate

Arm Description

Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.

Outcomes

Primary Outcome Measures

Radiographic bone volume
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.

Secondary Outcome Measures

Change of Pink and white esthetic scores (PES/WES)
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.
Visual analogue scale (VAS)
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
Oral health impact profile shortened version (OHIP-I)
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.
Buccal marginal recession
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.
Papilla volume
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Width of keratinized gingiva
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.
Implant survival
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Probing depth
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.
Modified plaque index
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.
Modified bleeding index
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.

Full Information

First Posted
September 14, 2017
Last Updated
February 8, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03319758
Brief Title
Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
Official Title
Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen 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 aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.
Detailed Description
The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate 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. At least 15 patients are recruited. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
Keywords
bone augmentation, esthetics, immediate implant, buccal bone defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thin or dehiscences buccal plate
Arm Type
Experimental
Arm Description
Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.
Intervention Type
Procedure
Intervention Name(s)
buccal bone augmentation
Intervention Description
Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.
Primary Outcome Measure Information:
Title
Radiographic bone volume
Description
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.
Time Frame
Up to 10 years after baseline
Secondary Outcome Measure Information:
Title
Change of Pink and white esthetic scores (PES/WES)
Description
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.
Time Frame
Change from baseline up to 10 years after implantation
Title
Visual analogue scale (VAS)
Description
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
Time Frame
Up to 10 years after baseline
Title
Oral health impact profile shortened version (OHIP-I)
Description
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.
Time Frame
Up to 10 years after baseline
Title
Buccal marginal recession
Description
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.
Time Frame
Up to 10 years after baseline
Title
Papilla volume
Description
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time Frame
Up to 10 years after baseline
Title
Width of keratinized gingiva
Description
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.
Time Frame
Up to 10 years after baseline
Title
Implant survival
Description
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time Frame
Up to 10 years after baseline
Title
Probing depth
Description
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.
Time Frame
Up to 10 years after baseline
Title
Modified plaque index
Description
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.
Time Frame
Up to 10 years after baseline
Title
Modified bleeding index
Description
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.
Time Frame
Up to 10 years after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The inclusion criteria were as follows: 18 to 70-year-old; Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II); Single maxillary anterior teeth (canine to canine); Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)； Presence of adjacent nature tooth; Good compliance; No palatal vertical bone loss; Good oral hygiene. Exclusion criteria are as follow: Uncontrolled periodontal or systemic disease; General psychiatric contraindications; More than 20 cigarettes per day; History of head and neck radiotherapy； Pregnant or expecting to be pregnant; Patients with local or generalized healing limitations; Bruxism or other destructive parafunctional habits; Drug abuse or alcohol abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoxin Huang, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25916859
Citation
Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.
Results Reference
result
PubMed Identifier
24684275
Citation
Barone A, Ricci M, Romanos GE, Tonelli P, Alfonsi F, Covani U. Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. Clin Oral Implants Res. 2015 Jul;26(7):823-30. doi: 10.1111/clr.12369. Epub 2014 Mar 31.
Results Reference
result
PubMed Identifier
26330931
Citation
Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. J Clin Exp Dent. 2015 Jul 1;7(3):e361-8. doi: 10.4317/jced.52292. eCollection 2015 Jul.
Results Reference
result

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Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

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