Clinical trial NCT03806608: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Jaw, Edentulous
Partial Edentulism
Keywords: Marginal Bone Loss
Implant depth
Crestal or Subcrestal
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Marginal bone loss(MBL)
timeFrame: Change from baseline up to 5 years after implantation
Secondary outcomes:
measure: Cumulative survival rate (CSR)
timeFrame: Up to 5 years after final restoration
measure: Pocket probing depth (PPD)
timeFrame: Up to 5 years after final restoration
measure: Plaque index (PI)
timeFrame: Up to 5 years after final restoration
measure: Bleeding on probing (BOP)
timeFrame: Up to 5 years after final restoration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen Unniversity
name: Baoxin Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.