Single Implant; Immediate Implant Treatment; Early Implant TreatmentNCT04653025
Immedaite vs Early Implant Placement in Aesthetic Area
A study testing Implant placement in people with Single Implant; Immediate Implant Treatment; Early Implant Treatment, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
Trial summary
The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Single Implant; Immediate Implant Treatment; Early Implant Treatment
- What is being tested?
- Implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2017to 10 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- no recession of gingival contour of tooth to be extracted,
- no periodontal bone loss of neighboring anterior teeth,
- no implants in neighboring teeth,
- class I extraction socket (intact buccal wall),
- atraumatic extraction of the tooth with intact socket walls remaining,
- only one implant per patient to be inserted.
Who cannot join
- deep bite (severe II class),
- systemic disease (diabetes, osteoporosis),
- heavy smokers (more than 10 cigarettes/day) were excluded.
- atraumatic extraction of the tooth failed,
- the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.
The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.
Read the detailed description
Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.
- Being tested
- Implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementDevice
After tooth extraction implants were placed either immediate or delayed approach
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Test group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting Receives: Device: Implant placement |
| Control group | Experimental | Patients in the control group received soft tissue grafting after tooth extraction and an implant with bone augmentation after 6 weeks of healing. Receives: Device: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pink aesthetic score (PES) over time
pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos.
Measured: Baseline, 1 year and 5 years after prosthetic delivery
Secondary outcomes (2)
Changes of marginal bone level (MBL) around implant neck
Periapical x-rays will be used to measure crestal bone sability distally and mesially of dental implant using certificated x-ray program after calibration. Measurement will be recorded in millimetres from implant neck to the first bone to implant contact
Measured: Baseline, 1 year and 5 years after prosthetic delivery
Recession changes of gingiva of restored tooth on the implant
Mid-buccal recession evaluation will be performed using standardised periodontal probe. Measurement of the crown hight will be done in the middle of the tooth from incisal edge to the highest point and recorded in millimetres.
Measured: Baseline, 1 year and 5 years after prosthetic delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 May 2017
- Primary completion10 Jan 2020
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Implant; Immediate Implant Treatment; Early Implant TreatmentStudies 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
- Model description
- Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) Klinika
- Sponsor type
- Research network
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Algirdas Puisys, DDS, PhD, Vilniaus Implantologijos Centro (VIC) Klinika
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653025
- Sponsor's protocol ID
- IIS0816
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04653025
- Acronym / sponsor ID
- IIS0816
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vilniaus Implantologijos Centro (VIC) KlinikaResearch network
- Collaborators
- Institut Straumann AG
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
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 randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.
Detailed description
Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Implant placementTest group patients received an immediate implant with provisional restoration, bone augmentation and soft tissue grafting |
| Control group | Experimental | Device: Implant placementPatients in the control group received soft tissue grafting after tooth extraction and an implant with bone augmentation after 6 weeks of healing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- no recession of gingival contour of tooth to be extracted,
- no periodontal bone loss of neighboring anterior teeth,
- no implants in neighboring teeth,
- class I extraction socket (intact buccal wall),
- atraumatic extraction of the tooth with intact socket walls remaining,
Key exclusion criteria (5 listed)
- deep bite (severe II class),
- systemic disease (diabetes, osteoporosis),
- heavy smokers (more than 10 cigarettes/day) were excluded.
- atraumatic extraction of the tooth failed,
- the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.
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 |
|---|---|---|
| Implant placementAfter tooth extraction implants were placed either immediate or delayed approach | Device | Control group, Test group |
Primary outcome
Changes of pink aesthetic score (PES) over time
Time frame: Baseline, 1 year and 5 years after prosthetic delivery
pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos.
2 secondary outcomes
Changes of marginal bone level (MBL) around implant neck
Time frame: Baseline, 1 year and 5 years after prosthetic delivery
Recession changes of gingiva of restored tooth on the implant
Time frame: Baseline, 1 year and 5 years after prosthetic delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement in people with Single Implant; Immediate Implant Treatment; Early Implant Treatment, run by Vilniaus Implantologijos Centro (VIC) Klinika at 1 site in Lithuania.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes of pink aesthetic score (PES) over time (time frame: Baseline, 1 year and 5 years after prosthetic delivery). 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 4 Dec 2020.