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

Not Applicable

Active, not recruiting

• Conditions: Jaw, Edentulous; Partial Edentulism
• Interventions: Procedure: Subcrestal; Procedure: Crestal

• Registration Number: NCT03806608
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2019-04-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcrestal	Subcrestal	Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge
Crestal	Crestal	Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge

Primary Outcome Measures

Name	Time	Method
Marginal bone loss(MBL)	Change from baseline up to 5 years after implantation	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.

Secondary Outcome Measures

Name	Time	Method
Plaque index (PI)	Up to 5 years after final restoration	Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration
Cumulative survival rate (CSR)	Up to 5 years after final restoration	Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration
Pocket probing depth (PPD)	Up to 5 years after final restoration	Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration
Bleeding on probing (BOP)	Up to 5 years after final restoration	Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration

Trial Locations

Locations (1)

Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China