Immediate Dental ImplantNCT04343833
Immediate Implants in the Aesthetic Zone
A study testing Immediate dental implants in people with Immediate Dental Implant, run by Universidad de Murcia at 1 site in Spain.
Trial summary
The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. 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
- What is being tested?
- Immediate dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2017to 4 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
- Good systemic health status (ASA I or II).
- Oral hygiene index of < 2 (Löe and Silness).
- A minimum of 2 mm of attached mucosa.
- A minimum of 8 mm of vertical bone.
- A minimum of 7 mm of bucco-lingual bone.
Who cannot join
- Traumatic or complicated incisor extraction.
- Pregnant or women in the lactation period.
- Use of any medication that contraindicates implant treatment.
- A history of alcohol or drug abuse.
- A requirement for guided bone regeneration.
- A requirement for tissue graft augmentation.
- Failure to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital
Murcia, 30008
About this study
Official title: Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study
The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.
Read the detailed description
20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p<0.05).
The random distribution is made prior to assignment following the internet prgram https://www.random.org
- Conditions
- Immediate Dental Implant
- Being tested
- Immediate dental implants
- Keywords
- Dental esthetics, Primary stability, Single-tooth restoration, Osseointegration.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implantsProcedure or surgery
Also called Fresh extraction sockets
At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.
| Study group | Role | What they receive |
|---|---|---|
| Control with Standard dental implant | Active comparator | Patients were treated with implants Inhex Ticare Standard (Mozo Grau, Ticare, Valladolid, Spain). The implants presented a surface treated with Reabsorbable Blast Media (RBM), conical macro-design with non-aggressive threads, internal connection, and platform switching. On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º. Receives: Procedure: Immediate dental implants |
| Test with the new implant design | Experimental | Patients were treated with Implants Inhex Quattro Ticare (Mozo Grau, Ticare, Valladolid, Spain). The implants also presented a surface treated with RBM, conical macro-design with expanded micro threads, internal connection, and platform switching.On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º. Receives: Procedure: Immediate dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone level
The bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant.
The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.
Measured: After 12 months of definitive implant load
PES/WES
Pink Esthetic Score/White Esthetic Score [PES/WES] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6
Measured: After 12 months of definitive implant load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start2 Oct 2017
- Primary completion16 Jan 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immediate Dental ImplantStudies 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
- A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Sánchez-Pérez, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343833
- Sponsor's protocol ID
- 2076/20018
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-personal data
Publications
Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.
PubMed 34625591
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study
- ClinicalTrials.gov ID
- NCT04343833
- Acronym / sponsor ID
- 2076/20018
- Conditions
- Immediate Dental Implant
- Keywords
- Dental esthetics, Primary stability, Single-tooth restoration, Osseointegration.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 13 Apr 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 use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.
Detailed description
20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p<0.05).
The random distribution is made prior to assignment following the internet prgram https://www.random.org
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.
| Arm | Type | Receives |
|---|---|---|
| Control with Standard dental implant | Active comparator | Procedure: Immediate dental implantsPatients were treated with implants Inhex Ticare Standard (Mozo Grau, Ticare, Valladolid, Spain). The implants presented a surface treated with Reabsorbable Blast Media (RBM), conical macro-design with non-aggressive threads, internal connection, and platform switching. On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º. |
| Test with the new implant design | Experimental | Procedure: Immediate dental implantsPatients were treated with Implants Inhex Quattro Ticare (Mozo Grau, Ticare, Valladolid, Spain). The implants also presented a surface treated with RBM, conical macro-design with expanded micro threads, internal connection, and platform switching.On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
- Good systemic health status (ASA I or II).
- Oral hygiene index of < 2 (Löe and Silness).
- A minimum of 2 mm of attached mucosa.
- A minimum of 8 mm of vertical bone.
Key exclusion criteria (7 listed)
- Traumatic or complicated incisor extraction.
- Pregnant or women in the lactation period.
- Use of any medication that contraindicates implant treatment.
- A history of alcohol or drug abuse.
- A requirement for guided bone regeneration.
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 dental implantsAlso: Fresh extraction socketsAt the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact. | Procedure or surgery | Control with Standard dental implant, Test with the new implant design |
Primary outcome
Bone level
Time frame: After 12 months of definitive implant load
The bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant. The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.
PES/WES
Time frame: After 12 months of definitive implant load
Pink Esthetic Score/White Esthetic Score [PES/WES] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Derived from this study: PubMed 34625591Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.
- Individual participant dataSharing planned: Yes. Non-personal data
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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 Immediate dental implants in people with Immediate Dental Implant, run by Universidad de Murcia at 1 site in Spain.
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 7 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 14 Apr 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone level (time frame: After 12 months of definitive implant load). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343833, which also lists 1 linked publication.
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 14 Apr 2020.