An interventional study of buccal bone augmentation in Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
The inclusion criteria were as follows:
Exclusion criteria are as follow:
Immediate implant placement used bone augmentation in combination with an absorbable collagen membrane with thin or dehiscences buccal plate.
Procedure: buccal 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.
Radiographic bone volume
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.
Time frame: Up to 10 years after baseline
Change of Pink and white esthetic scores (PES/WES)
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.
Time frame: Change from baseline up to 10 years after implantation
Visual analogue scale (VAS)
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
Time frame: Up to 10 years after baseline
Oral health impact profile shortened version (OHIP-I)
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.
Time frame: Up to 10 years after baseline
Buccal marginal recession
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.
Time frame: Up to 10 years after baseline
Papilla volume
Papilla volume will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time frame: Up to 10 years after baseline
Width of keratinized gingiva
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.
Time frame: Up to 10 years after baseline
Implant survival
Implant survival will be assessed at 0.5, 1, 1.5, 3.5, 5.5, 7.5, 10.5 years after implant placement.
Time frame: Up to 10 years after baseline
Probing depth
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.
Time frame: Up to 10 years after baseline
Modified plaque index
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.
Time frame: Up to 10 years after baseline
Modified bleeding index
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.
Time frame: Up to 10 years after baseline
Plan to share: Undecided
This study is active, not recruiting, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University