Esthetic, Clinical and Radiographic Outcomes of Immediate and Delayed Implant Placement

Jaw, Edentulous, Partially Clinical Trial

Official title:

Esthetic, Clinical and Radiographic Outcomes of Immediate Implant Placement and Delayed Implant Placement in the Anterior Region of the Maxilla

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02814149
• Other study ID #: XinL
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 2027

Study information

• Verified date: October 2019
• Source: Sun Yat-sen University
• Contact: Xin Liu
• Phone: +8615902064014
• Email: 838667172[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective cohort study is to compare the esthetic, clinical and patient-centered outcomes following immediate and delayed implant placement protocols.

Description:

Patients are divided into two groups: immediate and delayed implant placement. The investigators are asking subjects to take part in a research study of soft tissue and bone healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• At least 18 years old and able to understand an informed consent

• Adequate oral hygiene to allow for implant therapy consistent with standards of care.

• Missing a single tooth in the maxillary anterior region

• Presence of adjacent natural teeth

Exclusion Criteria:

• Poor oral hygiene

• Severe parafunctional habits, for example, bruxing and clenching

• Presence of clinically active periodontal disease as expressed by probing pocket depths=4 mm in combination with bleeding on probing.

• Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease

• Pregnant or expecting to be pregnant

• History of drug and alcohol abuse

• History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)

• Radiotherapy in the head and neck area,

• On certain medications like bisphosphonates or steroids currently or within the past three months

• Absence of adjacent teeth

• Unwillingness to return for the follow-up examination

• Smokers (more than 20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Type 1 implant placement
Implant is placed immediately following tooth extraction in one surgical procedure
• Type 3 implant placement
Implant is placed in the site which is left to heal for 3 months following tooth extraction

Locations

Country	Name	City	State
China	Guanghua School of Stomatology Hospital of Stomatology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Huynh-Ba G, Meister DJ, Hoders AB, Mealey BL, Mills MP, Oates TW, Cochran DL, Prihoda TJ, McMahan CA. Esthetic, clinical and patient-centered outcomes of immediately placed implants (Type 1) and early placed implants (Type 2): preliminary 3-month results of an ongoing randomized controlled clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):241-52. doi: 10.1111/clr.12577. Epub 2015 Mar 10. — View Citation

Rieder D, Eggert J, Krafft T, Weber HP, Wichmann MG, Heckmann SM. Impact of placement and restoration timing on single-implant esthetic outcome - a randomized clinical trial. Clin Oral Implants Res. 2016 Feb;27(2):e80-6. doi: 10.1111/clr.12539. Epub 2014 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 years after baseline
Primary	Radiographic bone volume	Radiographic bone volume be assessed at pre-operation, 0 ,1.5, 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
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	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