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

NCT03806608 | Active Not Recruiting DMC

• 1 other identifier: Baoxin Huang Depth
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Jaw, Edentulous; Partial Edentulism

Keywords

Marginal Bone Loss; Implant depth; Crestal or Subcrestal

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline up to 5 years after implantation

Secondary Outcomes (4)

• Cumulative survival rate (CSR)

  Up to 5 years after final restoration

• Pocket probing depth (PPD)

  Up to 5 years after final restoration

• Plaque index (PI)

  Up to 5 years after final restoration

• Bleeding on probing (BOP)

  Up to 5 years after final restoration

Study Arms (2)

Crestal

EXPERIMENTAL

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

Procedure: Crestal

Subcrestal

EXPERIMENTAL

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

Procedure: Subcrestal

Interventions

Crestal PROCEDURE

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).

Crestal

Subcrestal PROCEDURE

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).

Subcrestal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

Related Publications (4)

• 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.

  PMID: 24720447 BACKGROUND

• 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.

  PMID: 22220773 BACKGROUND

• 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.

  PMID: 24278924 BACKGROUND

• 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.

  PMID: 29313133 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Baoxin Huang, PhD

  Sun Yat-sen Unniversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: April 17, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)