Dental ImplantNCT06455436
Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments
A study testing Standard healing abutment and Individualized healing abutment in people with Dental Implant and Immediate Dental Implant, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Immediate Dental Implant, Wound Heal
- What is being tested?
- Standard healing abutment and Individualized healing abutment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2024to 15 Jul 2026
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient ( 25 years old).
- Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
- Presence of 2mm of keratinized gingiva.
- Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
- Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
- Plaque index (FMSPI, full mouth score plaque index) < 10%.
- Non-smokers or smokers of less than 10 cigarettes per day.
- Absence of systemic diseases that contraindicate implant surgery.
Who cannot join
- Presence of alveoli with dehiscence >2mm.
- Presence of adjacent implants.
- < 2mm of keratinized gingiva.
- Presence of active infection (fistula, suppuration) at the extraction site.
- Presence of apical granuloma >2mm in diameter in the root(s) of the tooth or teeth to be extracted.
- Residual bone apical to the extraction insufficient to anchor the implant.
Show all 13Show fewer
- Pregnant or lactating women.
- Severe cognitive or psychiatric disorders.
- Compromised general health status ( ASA IV).
- Use of drugs that alter bone metabolism and healing.
- Absence of manual primary stability of the implant
- Bone dehiscence or fenestration after implant placement (manual rotation).
- Gap 2mm between the implant and the vestibular bone wall.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Barcelona, Catalonia, 08195
Javi Vilarrasa, Mr, jvilarrasa@uic.es
About this study
Official title: Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.
Read the detailed description
Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.
Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.
- Conditions
- Dental Implant, Immediate Dental Implant, Wound Heal
- Being tested
- Standard healing abutment, Individualized healing abutment
- Keywords
- implant, soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard healing abutmentDevice
Participants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment
Individualized healing abutmentDevice
Participants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Will receive standard healing abutments Receives: Device: Standard healing abutment |
| Individualized healing abutment group | Experimental | Will receive individualized healing abutments Receives: Device: Individualized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal-lingual/palatal soft tissue dimensional changes
They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin).
Measured: 12 months
Secondary outcomes (10)
Dehiscence of peri-implant vestibular and lingual/palatal mucosa:
Dehiscence can be assessed by carefully examining the peri- implant mucosa for any signs of tissue separation or exposure. This can be done visually during clinical examination.
Measured: 12 months
Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)
To measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions. measure dimensional changes in the alveolar bone, you can use cone-beam computed tomography (CBCT) scans. Compare CBCT images taken at different time points to quantify any changes in bone dimensions.
Measured: 12 months
Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)
CBCT scans can also be used to assess horizontal remodeling of the cortical bone. Analyze the CBCT images to measure changes in cortical thickness or contour.
Measured: 12 months
Thickness of vestibular and lingual/palatal cortex (CBCT)
CBCT scans can provide measurements of cortical thickness in the vestibular and lingual/palatal regions of the alveolar bone.
Measured: 12 months
Vertical changes of the vestibular and lingual/palatine cortex (CBCT)
Use CBCT scans to measure any vertical changes in the vestibular and lingual/palatal cortical bone regions.
Measured: 12 months
Marginal bone level (periapical x-ray)
Periapical X-rays are commonly used to assess marginal bone levels around dental implants. Measure the distance from the implant-abutment interface to the crestal bone on these radiographs.
Measured: 12 months
Probing pocket depth
Probing pocket depth can be measured using periodontal probes. Insert the probe gently into the peri-implant sulcus and measure the distance from the mucosal margin to the implant-abutment interface.
Measured: 12 months
Bleeding/Suppuration on probing
Assess bleeding or suppuration during probing. Note if there is any bleeding or exudate from the peri-implant sulcus when probing the tissues.
Measured: 12 months
Implant survival
Implant survival can be determined by assessing whether the implant remains in place and functional over the study period. Any implant removals or failures should be documented.
Measured: 12 months
Patient-reported variables (satisfaction, pain)
Subjective assessment of pain intensity and patient satisfaction using a 10-cm visual analog scale. The extremes of the scale are the extreme expressions of pain and discomfort (i.e., no pain and the worst imaginable pain)
- Type of variable (units): scale (mm).
- Time of registration: Appointment 4 (surgery), Appointment 5 (follow-up), Appointment 10 (End of study)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start8 May 2024
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Albertini, PhD, Principal investigator, Universidad Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455436
- Sponsor's protocol ID
- PER-ECL-2023-10
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments Using a CAD/CAM Technique: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06455436
- Acronym / sponsor ID
- PER-ECL-2023-10
- Conditions
- Dental Implant, Immediate Dental Implant, Wound Heal
- Keywords
- implant, soft tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 12 Jun 2024 (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 loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.
Detailed description
Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.
Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Standard healing abutmentWill receive standard healing abutments |
| Individualized healing abutment group | Experimental | Device: Individualized healing abutmentWill receive individualized healing abutments |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patient ( 25 years old).
- Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
- Presence of 2mm of keratinized gingiva.
- Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
- Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
Key exclusion criteria (13 listed)
- Presence of alveoli with dehiscence >2mm.
- Presence of adjacent implants.
- < 2mm of keratinized gingiva.
- Presence of active infection (fistula, suppuration) at the extraction site.
- Presence of apical granuloma >2mm in diameter in the root(s) of the tooth or teeth to be extracted.
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 |
|---|---|---|
| Standard healing abutmentParticipants will undergo a surgery to place an immediate klockner dental implant and will be receive a standard healing abutment | Device | Control group |
| Individualized healing abutmentParticipants will undergo a surgery to place an immediate klockner dental implant and will be receive an individualized healing abutment | Device | Individualized healing abutment group |
Primary outcome
Buccal-lingual/palatal soft tissue dimensional changes
Time frame: 12 months
They will be evaluated after superimposing the initial STL files with the follow-up ones. In addition, photos, periapical radiographs and a new intraoral scan at 3 months, 6 months and 1 year will be taken. In a 2D buccal-lingual slice corresponding to the center of the ridge, measure at the vestibular and palatal level from the point of maximum preoperative STL soft tissue contour (mucosal margin and at 3 mm and 5 mm apical to the margin).
10 secondary outcomes
Dehiscence of peri-implant vestibular and lingual/palatal mucosa:
Time frame: 12 months
Vestibulo-lingual/palatal dimensional changes of the alveolar bone (CBCT)
Time frame: 12 months
Horizontal remodeling of vestibular and lingual/palatal cortex (CBCT)
Time frame: 12 months
Thickness of vestibular and lingual/palatal cortex (CBCT)
Time frame: 12 months
Vertical changes of the vestibular and lingual/palatine cortex (CBCT)
Time frame: 12 months
Marginal bone level (periapical x-ray)
Time frame: 12 months
Probing pocket depth
Time frame: 12 months
Bleeding/Suppuration on probing
Time frame: 12 months
Implant survival
Time frame: 12 months
Patient-reported variables (satisfaction, pain)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- 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.
Matteo Albertini, PhD principal investigator
Universidad Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard healing abutment and Individualized healing abutment in people with Dental Implant and Immediate Dental Implant, run by Universitat Internacional de Catalunya 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javi Vilarrasa, MSc (+34 628553000, jvilarrasa@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal-lingual/palatal soft tissue dimensional changes (time frame: 12 months). 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 12 Jun 2024.