Dental Implant TherapyNCT05975814
The Effect of Concave Healing Abutment on Soft Tissue Healing
A study testing dental implant in people with Dental Implant Therapy, run by MIS Implant Technologies, Ltd at 1 site in Israel.
Trial summary
The aim of this study is to document the relevance of the concave abutment to form more gingiva when compared to the straight abutment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dental Implant Therapy
- What is being tested?
- dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 1 Jan 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 18 years in need of implant therapy in the posterior area of the mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) < 15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an informed consent.
Who cannot join
- patients with a contributing medical history in which any surgery, disease, condition, or medication susceptible to compromise the healing of soft and hard tissues (e.g. non-controlled diabetes), b) liver function disorder, c) immune system disease, d) immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect healing, f) patients who have undergone chemotherapy or radiation treatment during the previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other medication that could influence postoperative healing and/or osseointegration, h) bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend follow-up visits, k) patients unwilling to sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Mis Implants Technologies Ltd.
Misgav Regional Council, 2015600
Michal Malka, +972547257128, michal.malka@dentsplysirona.com
Serge Szmukler, Dr, +972537085454, serge.szmukler@dentsplysirona.com
About this study
Official title: Effect of the Shape of the Healing Abutment on Soft Tissue Healing. A Randomized Clinical Study Involving an Enhanced Digital Superposition Methodology
The aim of this study is to document the relevance of the concave abutment to form more gingiva when compared to the straight abutment.
Read the detailed description
Standard clinical and radiographic examination will assess the need for implant therapy, the number of implants and the rehabilitation type. The pre-operative skeletal data will be observed with a 3D cone-beam computed tomographic examination (Cranex 3D, Soredex, Tuusula, Finland). On implantation day just before surgery, an initial intra-oral scan (TRIOS3, 3Shape, Copenhagen, Denmark) will be taken (IOS#0) to provide the baseline of the soft tissue outline. The surgical procedure will involve a crestal incision with 2 lateral discharge incisions; a full flap will be raised and the periosteum will be carefully separated from the cortical bone. The implant osteotomy will be prepared by executing the drilling sequence recommended by the manufacturer according to bone density; the final single-use drill that comes with each implant will be implemented on top of the drills when relevant. SEVEN (MIS) Ø 4.2 mm implants with an internal hex connection of appropriate length will be placed according to a 1-stage surgical protocol. They will receive a Ø 4.8 x 6 mm wide abutment, either straight or concave, according to the randomization. To anticipate early bone loss the implants will be seated slightly in a subcrestal position.
For single crown rehabilitations, a coin randomization will be performed to determine the abutment type, straight or concave; for plural restorations, randomization will start from the most distal implant. Height of all healing abutments will be 6 mm because this item provides the largest available mismatch concavity, 0.6 mm, compared to the straight abutment. After implant and abutment placement, the flap and periosteum will be reclined and sutured with single discontinued sutures around the abutments without tension. The patients will receive antibiotics (875/125 mg of Amoxicillin/Clavulanic acid, 3/d for 7 days; in case of penicillin allergy, 300 mg of Clindamycin every 6 h for 7 days) and analgesic anti-inflammatory treatment (600 mg Ibuprofen 3/d); rinsing with Chlorhexidine (0.12%) (Dentaid® PerioAid 0.12%) will be prescribed 2/d for 2 weeks. Sutures will be removed after 10 days (Cacaci et al., 2021). After a transmucosal soft tissue healing period of 6-8 weeks, the healed sites will be scanned (IOS#1).
- Conditions
- Dental Implant Therapy
- Being tested
- dental implant
- Keywords
- dental implants, concave abutments, intra-oral scans, CBCT, soft tissue thickness, randomized clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantDevice
dental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market.
| Study group | Role | What they receive |
|---|---|---|
| concave abutment vs. straight abutment | Experimental | After implant is placed a randomization will determine if the implant receives a straight or a concave abutment. If a patient requires 2 implants, one of them will be straight and the other will be concave. A patient can therefore have both abutments. Receives: Device: dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
The thickness of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides
Measured: end of healing, 6-8 weeks after implant surgery
Secondary outcomes (1)
Height of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
The height of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides
Measured: end of healing, 6-8 weeks after implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Apr 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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 Dental Implant TherapyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- clinical study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIS Implant Technologies, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Sachsen Praxen Zahnarztpraxis
- Responsible party
- Sponsor
- Investigators
- Rasmus Sperber, Dr, Principal investigator, Sachen Praxen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975814
- Sponsor's protocol ID
- MIS-CONCAVE
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.
PubMed 34551159
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Shape of the Healing Abutment on Soft Tissue Healing. A Randomized Clinical Study Involving an Enhanced Digital Superposition Methodology
- ClinicalTrials.gov ID
- NCT05975814
- Acronym / sponsor ID
- MIS-CONCAVE
- Conditions
- Dental Implant Therapy
- Keywords
- dental implants, concave abutments, intra-oral scans, CBCT, soft tissue thickness, randomized clinical study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MIS Implant Technologies, LtdIndustry (pharma, biotech, devices)
- Collaborators
- Charite University, Berlin, Germany, Sachsen Praxen Zahnarztpraxis
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 4 Aug 2023 (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 aim of this study is to document the relevance of the concave abutment to form more gingiva when compared to the straight abutment.
Detailed description
Standard clinical and radiographic examination will assess the need for implant therapy, the number of implants and the rehabilitation type. The pre-operative skeletal data will be observed with a 3D cone-beam computed tomographic examination (Cranex 3D, Soredex, Tuusula, Finland). On implantation day just before surgery, an initial intra-oral scan (TRIOS3, 3Shape, Copenhagen, Denmark) will be taken (IOS#0) to provide the baseline of the soft tissue outline. The surgical procedure will involve a crestal incision with 2 lateral discharge incisions; a full flap will be raised and the periosteum will be carefully separated from the cortical bone. The implant osteotomy will be prepared by executing the drilling sequence recommended by the manufacturer according to bone density; the final single-use drill that comes with each implant will be implemented on top of the drills when relevant. SEVEN (MIS) Ø 4.2 mm implants with an internal hex connection of appropriate length will be placed according to a 1-stage surgical protocol. They will receive a Ø 4.8 x 6 mm wide abutment, either straight or concave, according to the randomization. To anticipate early bone loss the implants will be seated slightly in a subcrestal position.
For single crown rehabilitations, a coin randomization will be performed to determine the abutment type, straight or concave; for plural restorations, randomization will start from the most distal implant. Height of all healing abutments will be 6 mm because this item provides the largest available mismatch concavity, 0.6 mm, compared to the straight abutment. After implant and abutment placement, the flap and periosteum will be reclined and sutured with single discontinued sutures around the abutments without tension. The patients will receive antibiotics (875/125 mg of Amoxicillin/Clavulanic acid, 3/d for 7 days; in case of penicillin allergy, 300 mg of Clindamycin every 6 h for 7 days) and analgesic anti-inflammatory treatment (600 mg Ibuprofen 3/d); rinsing with Chlorhexidine (0.12%) (Dentaid® PerioAid 0.12%) will be prescribed 2/d for 2 weeks. Sutures will be removed after 10 days (Cacaci et al., 2021). After a transmucosal soft tissue healing period of 6-8 weeks, the healed sites will be scanned (IOS#1).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical study
| Arm | Type | Receives |
|---|---|---|
| concave abutment vs. straight abutment | Experimental | Device: dental implantAfter implant is placed a randomization will determine if the implant receives a straight or a concave abutment. If a patient requires 2 implants, one of them will be straight and the other will be concave. A patient can therefore have both abutments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 18 years in need of implant therapy in the posterior area of the mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) < 15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an informed consent.
Key exclusion criteria (1 listed)
- patients with a contributing medical history in which any surgery, disease, condition, or medication susceptible to compromise the healing of soft and hard tissues (e.g. non-controlled diabetes), b) liver function disorder, c) immune system disease, d) immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect healing, f) patients who have undergone chemotherapy or radiation treatment during the previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other medication that could influence postoperative healing and/or osseointegration, h) bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend follow-up visits, k) patients unwilling to sign an informed consent form.
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 |
|---|---|---|
| dental implantdental implants are placed as usual and require a healing abutment. Abutments can be straight or concave, both are equally available on the market. | Device | concave abutment vs. straight abutment |
Primary outcome
Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
Time frame: end of healing, 6-8 weeks after implant surgery
The thickness of the gingiva will be measured on the superposition set including the STL of the abutments on the vestibular and lingual/palatal sides
1 secondary outcome
Height of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment
Time frame: end of healing, 6-8 weeks after implant surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publication: PubMed 34551159Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.
- 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.
Rasmus Sperber, Dr principal investigator
Sachen Praxen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant in people with Dental Implant Therapy, run by MIS Implant Technologies, Ltd at 1 site in Israel.
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 1 inclusion and 1 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 4 Aug 2023. 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 Israel. 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 Thilo Damaskos, Dr (+41 170 228 2816, thilo.damaskos@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the peri-implant gingiva at the level of the largest mismatch between the straight and the concave abutment (time frame: end of healing, 6-8 weeks after implant surgery). 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 NCT05975814, 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 4 Aug 2023.