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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03319758
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 138
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially; Acquired Absence of Single Tooth	Procedure: buccal bone augmentation	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
• Actual Study Start Date: May 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: thin or dehiscences buccal plate Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.	Procedure: buccal bone augmentation; 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.

Outcome Measures

Primary Outcome Measures

1. Radiographic bone volume [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.

Secondary Outcome Measures

1. Change of Pink and white esthetic scores (PES/WES) [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.

2. Visual analogue scale (VAS) [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) [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Baoxin Huang, PhD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baoxin Huang, Principal Investigator, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03319758
• Other Study ID Numbers: Baoxin Huang
• First Posted: Oct 24, 2017
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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, Principal Investigator, Sun Yat-sen University: bone augmentation; esthetics; immediate implant; buccal bone defects
• Additional relevant MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially

Study Results

No Results Posted as of Feb 9, 2021