NCT04653025

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
May 2017Jan 2030

Study Start

First participant enrolled

May 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
9.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2030

Expected
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

November 19, 2020

Last Update Submit

November 26, 2020

Conditions

Single Implant; Immediate Implant Treatment; Early Implant Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes of marginal bone level (MBL) around implant neck

    Baseline, 1 year and 5 years after prosthetic delivery

  • Recession changes of gingiva of restored tooth on the implant

    Baseline, 1 year and 5 years after prosthetic delivery

Study Arms (2)

Test group

EXPERIMENTAL

Test group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting

Device: Implant placement

Control group

EXPERIMENTAL

Patients in the control group received soft tissue grafting after tooth extraction and an implant with bone augmentation after 6 weeks of healing.

Device: Implant placement

Interventions

Implant placementDEVICE

After tooth extraction implants were placed either immediate or delayed approach

Control groupTest group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VIC clinic

Vilnius, 10205, Lithuania

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 4, 2020

Study Start

May 1, 2017

Primary Completion

January 10, 2020

Study Completion (Estimated)

January 10, 2030

Last Updated

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations

LI(1)