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

N/AActive Not RecruitingNCT03806608

Sun Yat-sen University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Jaw, Edentulous Partial Edentulism

Interventions

CrestalPROCEDURE

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).

SubcrestalPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline up to 5 years after implantation

Secondary Outcomes

Cumulative survival rate (CSR)

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

Pocket probing depth (PPD)

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

Plaque index (PI)

Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration

Time frame: Up to 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

Time frame: Up to 5 years after final restoration

Data from ClinicalTrials.gov

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