Immediate Loading Versus Delayed Loading in Single-implant

Immediate Dental Implant Loading Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770846
• Other study ID #: RCT01BG
• Secondary ID: Dnr 2011/125
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Fölktandvården Skåne AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immediate Dental Implant Loading

Intervention

Procedure:
• Immediate loading

• Delayed loading

Locations

Country	Name	City	State
Sweden	Centre of Dental Specialist Care	Malmö	Scania

Sponsors (1)

Lead Sponsor	Collaborator
Fölktandvården Skåne AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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