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

NCT ID: NCT03806608

Last Updated: 2022-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-17

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Jaw, Edentulous Partial Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Crestal

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

Group Type EXPERIMENTAL

Crestal

Intervention Type 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

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

Group Type EXPERIMENTAL

Subcrestal

Intervention Type 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).

Interventions

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Crestal

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

Subcrestal

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Baoxin Huang

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baoxin Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Unniversity

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24720447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22220773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24278924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29313133 (View on PubMed)

Other Identifiers

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Baoxin Huang Depth

Identifier Type: -

Identifier Source: org_study_id

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