Immediate Loading Versus Delayed Loading in Single-implant

Evaluation of Immediate Loading Versus Delayed Loading in Single-implant Restorations

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.

Study Overview

• Status: Completed
• Conditions: Immediate Dental Implant Loading
• Intervention / Treatment: Procedure: Immediate loading; Procedure: Delayed loading

Detailed Description

Purpose: The objective of the present prospective randomized clinical study was to compare the overall treatment outcome following immediate loading (IL) and delayed loading (DL) of single implants after 5 year of follow-up.

Patients with a missing maxillary tooth (15-25) were randomly assigned to IL or DL. The protocol included implant installation in healed sites, immediate loading, delayed loading, temporary screw-retained restoration, and replacement with a permanent single implant crown. Outcome measures were implant survival, marginal bone level, soft tissue changes, papillae index, pink, and white esthetic score (PES and WES), patient judged aesthetics, and oral health impact profile (OHiP-14).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Scania
    • Malmö, Scania, Sweden
      • Centre of Dental Specialist Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate loading; Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion	Procedure: Immediate loading
Active Comparator: Delayed loading; Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown.	Procedure: Delayed loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Folktandvården Skåne AB
• Investigators: Study Director: Ann Wennerberg, DDS, Phd, Malmö University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: RCT01BG; Dnr 2011/125 (Other Identifier: Regional Ethical Review Board in Lund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO