Edentulous Alveolar RidgeNABUTNCT06182670
The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement
A study testing Gingival Former Abutment, Subcrestal Implant and Healing Abutment in people with Edentulous Alveolar Ridge, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Gingival Former Abutment, Subcrestal Implant and Healing Abutment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 6 Jun 2021to 7 Jun 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to comprehend and sign informed consent.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Good oral health (no decay, periapical or periodontal lesions, PI and BOP <25%).
- Patient with posterior single missing tooth:
- for at least 5 months,
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- mandibular or maxillary,
- intercalated (distance between teeth more than 7.5 mm),
- at least 11 mm of height residual bone (from bone crest to maxillary sinus or inferior alveolar nerve),
- at least 5 mm of bone width (buccal - palatal/lingual).
- Availability for the 12-month duration of the study.
Who cannot join
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers more than 10 cigarettes per day.
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
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- Pregnant or lactating women.
- Parafunctions like bruxism.
- Previous interventions to increase bone thickness in the implant area.
- Current or past assumption of medications that may influence surgical therapy and/or interfere with healing following surgical treatment.
- Systemic diseases that constitute a contraindication to surgical therapy and/or interfere with healing following surgical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement: 12-months, Parallel, Randomized Clinical Trial
The present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement.
The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA.
Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.
Read the detailed description
According to current literature, physiological bone loss around oral implants is expected after placement and load (1 mm during the first year and 0.2 mm each subsequent year). Different implant designs and surgical protocols have been tested to minimize bone resorption, and subcrestal implant placement partially seems to overcome this issue. However, if this procedure increases the length of the transmucosal tunnel, increasing the risk of peri-implant soft tissue infection.
The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures. Our objective is to validate or deny this claim.
The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design. The trial will have a one-year duration, with data collection at the surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will be the assessment of the peri-implant soft tissues.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Gingival Former Abutment, Subcrestal Implant, Healing Abutment, Prosthetic Crown, Crestal Implant
- Keywords
- Oral Implants, Abutment, Subcrestal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Former AbutmentDevice
GFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel.
Subcrestal ImplantProcedure or surgery
Placement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone.
Healing AbutmentDevice
A healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization.
Prosthetic CrownDevice
A zirconia prosthetic crown finalizes the implant rehabilitation.
Crestal ImplantProcedure or surgery
Placement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone.
| Study group | Role | What they receive |
|---|---|---|
| Subcrestal implant and gingival former abutment (GFA) | Experimental | The subjects receive a subcrestal implant and a prosthodontic device (GFA) immediately during the surgery. The GFA will not be removed upon prosthetic load. It will be an integral part of the prosthetic finalization. Receives: Device: Gingival Former Abutment; Procedure: Subcrestal Implant; Device: Prosthetic Crown |
| Crestal implant and traditional abutment | Active comparator | The subjects receive a crestal implant and healing abutment. The healing abutment will be replaced by a definitive abutment to the prosthetic load. Receives: Device: Healing Abutment; Device: Prosthetic Crown; Procedure: Crestal Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Marginal Bone Level (MBL)
The reabsorption of the bone measured through radiographically change on standardised radiographs. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: Surgery, 3, 9 and 15 months
Secondary outcomes (4)
Change in PD (periodontal depth) (implant site)
Change in periodontal depth value (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3, 9 and 15 months
Change in REC (Clinical Gingival Recession) (implant site)
Change in recession value should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3, 9 and 15 months
Change in BOP (Bleeding on Probing) (implant site)
Change in percentage of sites positive to bleeding on probing (4 point each situ). Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3, 9 and 15 months
Change in PI (Plaque Index) (implant site)
Change in percentage of site with plaque (4 point each situ). Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3, 9 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start6 Jun 2021
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Monocentric, single blinded, randomized clinical trial, parallel design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Magda Mensi, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182670
- Sponsor's protocol ID
- NABUT NP 4078
- Acronym
- NABUT
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a New Prosthodontics Device in Hard and Soft Tissue Changes After Subcrestal Implant Placement: 12-months, Parallel, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06182670
- Acronym / sponsor ID
- NABUT / NABUT NP 4078
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- Oral Implants, Abutment, Subcrestal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 27 Dec 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 present randomized controlled trial aims to assess the influence of a new prosthodontics device (Gingival Former Abutment -GFA) on peri-implant bone loss and soft tissue changes and health after subcrestal oral implant placement.
The participants will be divided in two groups and receive either crestal implant placement and traditional healing abutment or subcrestal implant placement and GFA.
Clinical and radiographic examination will be performed at implant placement surgery, prosthetic load, 6 and 12 months follow-up.
Detailed description
According to current literature, physiological bone loss around oral implants is expected after placement and load (1 mm during the first year and 0.2 mm each subsequent year). Different implant designs and surgical protocols have been tested to minimize bone resorption, and subcrestal implant placement partially seems to overcome this issue. However, if this procedure increases the length of the transmucosal tunnel, increasing the risk of peri-implant soft tissue infection.
The GFA was created to limit both the loss of peri-implant crestal bone and the extension of the transmucosal tunnel. The GFA follows the "one abutment one time" concept, which is believed to limit disturbances of the peri-implant hard and soft tissues healing due to the removal of the traditional healing abutments during prosthetic load procedures. Our objective is to validate or deny this claim.
The study is a monocentric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design. The trial will have a one-year duration, with data collection at the surgical phase, at implant load and 6 and 12 months after load. The primary outcome will be radiographical MBL (marginal bone level) changes around the implant. Secondary outcomes will be the assessment of the peri-implant soft tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric, single blinded, randomized clinical trial, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Subcrestal implant and gingival former abutment (GFA) | Experimental | Device: Gingival Former Abutment, Procedure: Subcrestal Implant, Device: Prosthetic CrownThe subjects receive a subcrestal implant and a prosthodontic device (GFA) immediately during the surgery. The GFA will not be removed upon prosthetic load. It will be an integral part of the prosthetic finalization. |
| Crestal implant and traditional abutment | Active comparator | Device: Healing Abutment, Device: Prosthetic Crown, Procedure: Crestal ImplantThe subjects receive a crestal implant and healing abutment. The healing abutment will be replaced by a definitive abutment to the prosthetic load. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to comprehend and sign informed consent.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Good oral health (no decay, periapical or periodontal lesions, PI and BOP <25%).
- Patient with posterior single missing tooth:
Key exclusion criteria (11 listed)
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Smokers more than 10 cigarettes per day.
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
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 |
|---|---|---|
| Gingival Former AbutmentGFA is positioned on the sub-crestal implant during the surgery and it is no longer removed. This follows the "one abutment one time" concept and should prevent bone loss and transmucosal tunnel. | Device | Subcrestal implant and gingival former abutment (GFA) |
| Subcrestal ImplantPlacement of the endosseous sub-crestal dental implant through dedicated drills with 35 Newton insertion torque. It is positioned 2 mm under the crestal bone. | Procedure or surgery | Subcrestal implant and gingival former abutment (GFA) |
| Healing AbutmentA healing abutment is positioned on crestal implant during surgery. It is removed at prosthetic finalization. | Device | Crestal implant and traditional abutment |
| Prosthetic CrownA zirconia prosthetic crown finalizes the implant rehabilitation. | Device | Crestal implant and traditional abutment, Subcrestal implant and gingival former abutment (GFA) |
| Crestal ImplantPlacement of the endosseous crestal implant through dedicated drills with 35 Newton insertion torque at level of the alveolar bone. | Procedure or surgery | Crestal implant and traditional abutment |
Primary outcome
Change in Marginal Bone Level (MBL)
Time frame: Surgery, 3, 9 and 15 months
The reabsorption of the bone measured through radiographically change on standardised radiographs. Baseline values will be compared to the values recorded in the follow-up visits.
4 secondary outcomes
Change in PD (periodontal depth) (implant site)
Time frame: 3, 9 and 15 months
Change in REC (Clinical Gingival Recession) (implant site)
Time frame: 3, 9 and 15 months
Change in BOP (Bleeding on Probing) (implant site)
Time frame: 3, 9 and 15 months
Change in PI (Plaque Index) (implant site)
Time frame: 3, 9 and 15 months
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 27 Dec 2023.
- 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.
Magda Mensi principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival Former Abutment, Subcrestal Implant and Healing Abutment in people with Edentulous Alveolar Ridge, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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 11 inclusion and 11 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 27 Dec 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 Italy. 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?
Change in Marginal Bone Level (MBL) (time frame: Surgery, 3, 9 and 15 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 27 Dec 2023.