Jaw, Edentulous, Partially Clinical Trial
Official title:
Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
Verified date | February 2021 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | November 2027 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Aloy-Prósper A, Peñarrocha-Oltra D, Peñarrocha-Diago M, Peñarrocha-Diago M. Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. J Clin Exp Dent. 2015 Jul 1;7(3):e361-8. doi: 10.4317/jced.52292. eCollection — View Citation
Barone A, Ricci M, Romanos GE, Tonelli P, Alfonsi F, Covani U. Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. Clin Oral Implants Res. 2015 Jul;26(7):823-30. doi: 10.1111/clr.12369. Epub 2014 Mar 31. — View Citation
Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Change from baseline up to 10 years after implantation | |
Secondary | 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 | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline | |
Secondary | 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. | Up to 10 years after baseline |
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