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

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Jaw, Edentulous; Partial Edentulism

Treatments: Procedure: Crestal; Procedure: Subcrestal

Study type: Interventional

Funder types: Other

Identifiers

NCT03806608

Baoxin Huang Depth

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Crestal

Experimental group

Description:

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

Treatment:

Procedure: Crestal

Subcrestal

Experimental group

Description:

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

Treatment:

Procedure: Subcrestal