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Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT

Primary Purpose

Jaw, Edentulous, Partial Edentulism

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Crestal
Subcrestal
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 focused on measuring Marginal Bone Loss, Implant depth, Crestal or Subcrestal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;
  2. Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment;
  3. Periodontally healthy.

Exclusion Criteria:

  1. Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer;
  2. Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control;
  3. Parafunctional habits, such as the grinding or clenching of teeth;
  4. Smoking habit (more than 10 cigarettes per day);
  5. Pregnancy and breastfeeding.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Crestal

Subcrestal

Arm Description

Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge

Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge

Outcomes

Primary Outcome Measures

Marginal bone loss(MBL)
Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.

Secondary Outcome Measures

Cumulative survival rate (CSR)
Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration
Pocket probing depth (PPD)
Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration
Plaque index (PI)
Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration
Bleeding on probing (BOP)
Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration

Full Information

First Posted
January 14, 2019
Last Updated
April 19, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03806608
Brief Title
Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT
Official Title
Clinical and Radiographic Evaluation of Marginal Bone Changes Around Platform-switching Implants Placed in Crestal or Subcrestal Positions: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (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 objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest
Detailed Description
The objective of this randomized controlled trial is to evaluate changes in marginal bone levels and soft tissue dimensions around implants placed with the IAI at different positions in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at 1year, 3 years, 5 years after final restoration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partial Edentulism
Keywords
Marginal Bone Loss, Implant depth, Crestal or Subcrestal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crestal
Arm Type
Experimental
Arm Description
Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge
Arm Title
Subcrestal
Arm Type
Experimental
Arm Description
Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge
Intervention Type
Procedure
Intervention Name(s)
Crestal
Intervention Description
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
Intervention Type
Procedure
Intervention Name(s)
Subcrestal
Intervention Description
Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
Primary Outcome Measure Information:
Title
Marginal bone loss(MBL)
Description
Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.
Time Frame
Change from baseline up to 5 years after implantation
Secondary Outcome Measure Information:
Title
Cumulative survival rate (CSR)
Description
Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration
Time Frame
Up to 5 years after final restoration
Title
Pocket probing depth (PPD)
Description
Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration
Time Frame
Up to 5 years after final restoration
Title
Plaque index (PI)
Description
Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration
Time Frame
Up to 5 years after final restoration
Title
Bleeding on probing (BOP)
Description
Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration
Time Frame
Up to 5 years after final restoration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Absence of 2-4 teeth in the posterior region of the maxilla or mandibular; Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with no need for hard or soft tissue augmentation for implant treatment; Periodontally healthy. Exclusion Criteria: Systemic diseases that may affect bone and soft tissue healing, such as diabetes, osteoporosis, Paget's disease, and patients with cancer; Uncontrolled periodontal disease or poor oral health with neither good nor adequate plaque control; Parafunctional habits, such as the grinding or clenching of teeth; Smoking habit (more than 10 cigarettes per day); Pregnancy and breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoxin Huang, PhD
Organizational Affiliation
Sun Yat-sen Unniversity
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
24720447
Citation
Huang B, Meng H, Zhu W, Witek L, Tovar N, Coelho PG. Influence of placement depth on bone remodeling around tapered internal connection implants: a histologic study in dogs. Clin Oral Implants Res. 2015 Aug;26(8):942-949. doi: 10.1111/clr.12384. Epub 2014 Apr 10.
Results Reference
background
PubMed Identifier
22220773
Citation
Huang B, Meng H, Piao M, Xu L, Zhang L, Zhu W. Influence of placement depth on bone remodeling around tapered internal connection implant: a clinical and radiographic study in dogs. J Periodontol. 2012 Sep;83(9):1164-71. doi: 10.1902/jop.2012.110617. Epub 2012 Jan 5.
Results Reference
background
PubMed Identifier
24278924
Citation
Koutouzis T, Neiva R, Nonhoff J, Lundgren T. Placement of implants with platform-switched Morse taper connections with the implant-abutment interface at different levels in relation to the alveolar crest: a short-term (1-year) randomized prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1553-63. doi: 10.11607/jomi.3184.
Results Reference
background
PubMed Identifier
29313133
Citation
Valles C, Rodriguez-Ciurana X, Clementini M, Baglivo M, Paniagua B, Nart J. Influence of subcrestal implant placement compared with equicrestal position on the peri-implant hard and soft tissues around platform-switched implants: a systematic review and meta-analysis. Clin Oral Investig. 2018 Mar;22(2):555-570. doi: 10.1007/s00784-017-2301-1. Epub 2018 Jan 8.
Results Reference
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Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT

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