Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement
- Conditions
- Acquired Absence of Single ToothJaw, Edentulous, Partially
- Interventions
- Procedure: Type 1 implant placementProcedure: Type 3 implant placement
- Registration Number
- NCT02814149
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.
- Detailed Description
Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- At least 18 years old and able to understand an informed consent
- Adequate oral hygiene to allow for implant therapy consistent with standards of care.
- Missing a single tooth in the maxillary anterior region
- Presence of adjacent natural teeth
- Poor oral hygiene
- Severe parafunctional habits, for example, bruxing and clenching
- Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing.
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
- Pregnant or expecting to be pregnant
- History of drug and alcohol abuse
- History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
- Radiotherapy in the head and neck area,
- On certain medications like bisphosphonates or steroids currently or within the past three months
- Absence of adjacent teeth
- Unwillingness to return for the follow-up examination
- Smokers (more than 20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Type 1 implant placement Type 1 implant placement Implant is placed immediately following tooth extraction in one surgical procedure Type 3 implant placement Type 3 implant placement Implant is placed in the site which is left to heal for 3 months following tooth extraction
- Primary Outcome Measures
Name Time Method Pink and white esthetic scores (PES/WES) Up to 10 years after baseline Baseline will be at the time of implant placement.Pink and white esthetic scores (PES/WES) will be recorded at 0.5, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Radiographic bone volume Up to 10 years after baseline Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
- Secondary Outcome Measures
Name Time Method Implant survival Up to 10 years after baseline Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Modified bleeding index Up to 10 years after baseline Modified bleeding index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Buccal marginal recession Up to 10 years after baseline Buccal marginal recession will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Papilla volume Up to 10 years after baseline Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Probing depth Up to 10 years after baseline Probing depth will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Modified plaque index Up to 10 years after baseline Modified plaque index will be assessed at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Width of keratinized gingiva Up to 10 years after baseline Width of keratinized gingiva will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Visual analogue scale (VAS) Up to 10 years after baseline A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Oral health impact profile shortened version (OHIP-I) Up to 10 years after baseline A questionnaire will be recorded at pre-operation, 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Trial Locations
- Locations (1)
Guanghua School of Stomatology Hospital of Stomatology
🇨🇳Guangzhou, Guangdong, China