Active, Not Recruiting

NCT Number: NCT04653025

Immedaite vs Early Implant Placement in Aesthetic Area

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Single Implant; Immediate Implant Treatment; Early Implant Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIC clinic

Vilnius, 10205, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

no recession of gingival contour of tooth to be extracted,
no periodontal bone loss of neighboring anterior teeth,
no implants in neighboring teeth,
class I extraction socket (intact buccal wall),
atraumatic extraction of the tooth with intact socket walls remaining,
only one implant per patient to be inserted.

Exclusion criteria

deep bite (severe II class),
systemic disease (diabetes, osteoporosis),
heavy smokers (more than 10 cigarettes/day) were excluded.
atraumatic extraction of the tooth failed,
the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.

Treatment and study plan

Implant placement

Device

After tooth extraction implants were placed either immediate or delayed approach

Primary outcomes

Changes of pink aesthetic score (PES) over time

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

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.

Secondary outcomes

Changes of marginal bone level (MBL) around implant neck

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

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
Recession changes of gingiva of restored tooth on the implant

Time frame: Baseline, 1 year and 5 years after prosthetic delivery

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.

Sponsors and collaborators

Lead sponsor

Vilniaus Implantologijos Centro (VIC) Klinika

Network

Collaborators

Institut Straumann AG

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2030
First posted: Dec 4, 2020
Registry last updated: Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.