Immediate Dental Implant LoadingNCT02770846
Immediate Loading Versus Delayed Loading in Single-implant
A study testing Immediate loading and Delayed loading in people with Immediate Dental Implant Loading, run by Folktandvården Skåne AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant Loading
- What is being tested?
- Immediate loading and Delayed loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- General contraindications for oral surgery
- Inadequate oral hygiene
- Insufficient bone volume at the recipient site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Immediate Dental Implant Loading
- Being tested
- Immediate loading, Delayed loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loadingProcedure or surgery
Delayed loadingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading | Experimental | Immediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion Receives: Procedure: Immediate loading |
| Delayed loading | Active comparator | Delayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown. Receives: Procedure: Delayed loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2011
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Immediate Dental Implant LoadingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folktandvården Skåne AB
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Wennerberg, DDS, Phd, Study director, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770846
- Sponsor's protocol ID
- RCT01BG
- Other IDs
- Dnr 2011/125
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2016
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediate Loading Versus Delayed Loading in Single-implant Restorations
- ClinicalTrials.gov ID
- NCT02770846
- Acronym / sponsor ID
- RCT01BG
- Conditions
- Immediate Dental Implant Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Folktandvården Skåne ABUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate loading | Experimental | Procedure: Immediate loadingImmediate loading of single dental implant in the anterior maxilla with temporary crown in central occlusion |
| Delayed loading | Active comparator | Procedure: Delayed loadingDelayed loading. 2-stage procedure with a 4 months healing period before fabrication of temporary crown. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- General contraindications for oral surgery
- Inadequate oral hygiene
- Insufficient bone volume at the recipient site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate loading | Procedure or surgery | Immediate loading |
| Delayed loading | Procedure or surgery | Delayed loading |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Wennerberg, DDS, Phd study director
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate loading and Delayed loading in people with Immediate Dental Implant Loading, run by Folktandvården Skåne AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of Marginal Bone (time frame: Baseline to 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.