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

Partial Edentulism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03806608
• Other study ID #: Baoxin Huang Depth
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: May 2026

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Partial Edentulism

Intervention

Procedure:
• 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).
• 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).

Locations

Country	Name	City	State
China	Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Valles C, Rodríguez-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative survival rate (CSR)	Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration	Up to 5 years after final restoration
Secondary	Pocket probing depth (PPD)	Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration	Up to 5 years after final restoration
Secondary	Plaque index (PI)	Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration	Up to 5 years after final restoration
Secondary	Bleeding on probing (BOP)	Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration	Up to 5 years after final restoration