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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03319758
Other study ID # Baoxin Huang
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date November 2027

Study information

Verified date February 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

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.

Locations

Country Name City State
China Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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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