Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03319758
• Other study ID #: Baoxin Huang
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acquired Absence of Single Tooth
• Jaw, Edentulous
• Jaw, Edentulous, Partially

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