Acquired Absence of Single Tooth, Jaw, Edentulous, Partially
Conditions
Keywords
bone augmentation, esthetics, immediate implant, buccal bone defects
Brief summary
The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.
Detailed description
The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a final impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.
Interventions
PROCEDUREbuccal bone augmentation
Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria were as follows: 1. 18 to 70-year-old; 2. Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II); 3. Single maxillary anterior teeth (canine to canine); 4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)； 5. Presence of adjacent nature tooth; 6. Good compliance; 7. No palatal vertical bone loss; 8. Good oral hygiene.
Exclusion criteria
are as follow: 1. Uncontrolled periodontal or systemic disease; 2. General psychiatric contraindications; 3. More than 20 cigarettes per day; 4. History of head and neck radiotherapy； 5. Pregnant or expecting to be pregnant; 6. Patients with local or generalized healing limitations; 7. Bruxism or other destructive parafunctional habits; 8. Drug abuse or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone volume | Up to 10 years after baseline | Radiographic bone volume be assessed at pre-operation, 0 ,0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change of Pink and white esthetic scores (PES/WES) | Change from baseline up to 10 years after implantation | 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed