NCT02770846

Brief Summary

The purpose of this prospective randomized clinical study was to compare implant survival, patient satisfaction, and radiographic, clinical, and aesthetic outcomes following immediate loading (IL) and delayed loading (DL) of single dental implants after 1,3 and 5 years of follow-up.

Trial Health

87
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
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 26, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

4.7 years

First QC Date

April 26, 2016

Results QC Date

February 4, 2020

Last Update Submit

March 13, 2020

Conditions

Immediate Dental Implant Loading

Outcome Measures

Primary Outcomes (10)

  • Change in Level of Marginal Bone

    Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.

    Baseline to 12 months

  • Pink Esthetic Score

    The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

    After 12 months

  • Oral Health Impact Profile 14

    The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.

    Pre-surgery

  • White Esthetic Score

    The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

    Baseline

  • Pink Esthetic Score

    The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

    Baseline

  • Oral Health Impact Profile 14 (OHIP-14)

    The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life. The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement. The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined. Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life.

    After 12 months

  • White Esthetic Score

    The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

    After 12 months

  • Change in Level of Marginal Bone

    Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.

    Baseline to 5 years

  • Pink Esthetic Score

    The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated. The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined. Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome.

    After 5 year

  • White Esthetic Score

    The White esthetic score (WES) measures the aesthetic appearance of the implant crown. Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated. The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined. Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome.

    5 years

Study Arms (2)

Immediate loading

EXPERIMENTAL

Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion

Procedure: Immediate loading

Delayed loading

ACTIVE COMPARATOR

Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.

Procedure: Delayed loading

Interventions

Immediate loadingPROCEDURE
Immediate loading
Delayed loadingPROCEDURE
Delayed loading

Eligibility Criteria

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

You may qualify if:

  • Patients of at least 18 years of age.
  • In need of one or more single-tooth replacements.
  • The single-tooth replacement needs to be in the anterior maxilla
  • Minimum of mesial-distal width of interdental space of 6 mm

You may not qualify if:

  • General contraindications for oral surgery
  • Inadequate oral hygiene
  • Insufficient bone volume at the recipient site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Dental Specialist Care

Malmo, Skåne County, Sweden

Location

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Results Point of Contact

Title
Björn Gjelvold
Organization
Folktandvården Skåne AB
bjorn.gjelvold@gmail.com
+46709467870

Study Officials

  • Ann Wennerberg, DDS, Phd

    Malmö University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2016

First Posted

May 12, 2016

Study Start

April 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2019

Last Updated

March 26, 2020

Results First Posted

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)