Immedaite vs Early Implant Placement in Aesthetic Area

Single Implant; Immediate Implant Treatment; Early Implant Treatment Clinical Trial

Official title:

Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04653025
• Other study ID #: IIS0816
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 10, 2030

Study information

• Verified date: November 2020
• Source: Vilniaus Implantologijos Centro (VIC) Klinika
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.

Description:

Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 10, 2030
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. no recession of gingival contour of tooth to be extracted,

2. no periodontal bone loss of neighboring anterior teeth,

3. no implants in neighboring teeth,

4. class I extraction socket (intact buccal wall),

5. atraumatic extraction of the tooth with intact socket walls remaining,

6. only one implant per patient to be inserted.

Exclusion Criteria:

1. deep bite (severe II class),

2. systemic disease (diabetes, osteoporosis),

3. heavy smokers (more than 10 cigarettes/day) were excluded.

4. atraumatic extraction of the tooth failed,

5. the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.

Related Conditions & MeSH terms

• Single Implant; Immediate Implant Treatment; Early Implant Treatment

Intervention

Device:
• Implant placement
After tooth extraction implants were placed either immediate or delayed approach

Locations

Country	Name	City	State
Lithuania	VIC clinic	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilniaus Implantologijos Centro (VIC) Klinika	Institut Straumann AG

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of pink aesthetic score (PES) over time	pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos.	Baseline, 1 year and 5 years after prosthetic delivery
Secondary	Changes of marginal bone level (MBL) around implant neck	Periapical x-rays will be used to measure crestal bone sability distally and mesially of dental implant using certificated x-ray program after calibration. Measurement will be recorded in millimetres from implant neck to the first bone to implant contact	Baseline, 1 year and 5 years after prosthetic delivery
Secondary	Recession changes of gingiva of restored tooth on the implant	Mid-buccal recession evaluation will be performed using standardised periodontal probe. Measurement of the crown hight will be done in the middle of the tooth from incisal edge to the highest point and recorded in millimetres.	Baseline, 1 year and 5 years after prosthetic delivery