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Completed

NCT Number: NCT02770846

Immediate Loading Versus Delayed Loading in Single-implant

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.

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Key information

Conditions

Immediate Dental Implant Loading

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Dental Specialist Care

Malmö, Skåne County, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Immediate loading

Procedure

Delayed loading

Procedure

Primary outcomes

  1. Change in Level of Marginal Bone

    Time frame: Baseline to 12 months

    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.

  2. Pink Esthetic Score

    Time frame: After 12 months

    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.

  3. Oral Health Impact Profile 14

    Time frame: Pre-surgery

    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.

  4. White Esthetic Score

    Time frame: Baseline

    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. Pink Esthetic Score

    Time frame: Baseline

    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.

  6. Oral Health Impact Profile 14 (OHIP-14)

    Time frame: After 12 months

    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.

  7. White Esthetic Score

    Time frame: After 12 months

    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.

  8. Change in Level of Marginal Bone

    Time frame: Baseline to 5 years

    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.

  9. Pink Esthetic Score

    Time frame: After 5 year

    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.

  10. White Esthetic Score

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Folktandvården Skåne AB

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2019
First posted
May 12, 2016
Registry last updated
Mar 26, 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.

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