Acquired Absence of Single Tooth, Jaw, Edentulous, Partially
Conditions
Keywords
delayed implant, esthetics, immediate implant, bone augmentation
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.
Interventions
PROCEDUREType 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
PROCEDUREType 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactXin Liu
Backup ContactBaoxin Huang
Outcome results
None listed