Tooth Extraction Status NosIIP/ARP/SHNCT04367766
Management of the Fresh Extraction Socket in the Aesthetic Area
A study testing Prosthetically driven implant placement in people with Tooth Extraction Status Nos and Dental Implant, run by Centro Specialistico Odontoiatrico, Rome at 1 site in Italy.
Trial summary
After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts: 1. Immediate Implant Placement and Immediate Provisionalization 2. Alveolar Ridge Preservation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Status Nos, Dental Implant, Bone Augmentation
- What is being tested?
- Prosthetically driven implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2023to Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
- smoking no more than 10 cigarettes/day,
- periodontal health (BoP < 10%) and good plaque control (< 20%)
- absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
- extraction sites with less than 30% loss of one or more walls
- adequate quantity and quality of native bone to achieve primary stability
Who cannot join
- growing patients
- patients with autoimmune disease, uncontrolled diabetes or immunocompromised
- history of head and neck radiation for cancer treatment,
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Specialistico Odontoiatrico (CSO)
Roma
Marco Clementini, DDS, PhD, mclementini@me.com
About this study
Official title: Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement
After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:
- Immediate Implant Placement and Immediate Provisionalization
- Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
- Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.
Read the detailed description
The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:
- patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
- cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
- volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
- clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
- Implant Success and Survival at 1, 3 and 5 years after final prosthesis.
- Being tested
- Prosthetically driven implant placement
- Keywords
- Immediate implant placement, alveolar ridge preservation, delayed implant placement, PROMs, implant health, volumetric analysis, tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetically driven implant placementProcedure or surgery
Also called Prosthetically driven implant installation
Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant Placement | Active comparator | prosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization. Receives: Procedure: Prosthetically driven implant placement |
| Alveolar Ridge Preservation (ARP) + Delayed Implant Placement: | Active comparator | ARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm Receives: Procedure: Prosthetically driven implant placement |
| Spontaneous Healing + Delayed Implant Placement | Active comparator | extraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm . Receives: Procedure: Prosthetically driven implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adjunctive bone and soft tissue augmentation procedures need.
Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness < 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.
Measured: during implant placement
Secondary outcomes (1)
Peri-Implant Health
Peri-implant health will be assessed as a frequency (Yes/No) at 1, 3, 5 years after prosthetic crown delivery by a blinded examiner in case of: absence of clinical signs of inflammation, absence of bleeding and/or suppuration on gentle probing, no increase in probing depth compared to previous examinations, absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling
Measured: 1, 3, 5 years post loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start27 Sep 2023
- Primary completionApr 2024 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth Extraction Status NosStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Specialistico Odontoiatrico, Rome
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Marco Clementini, Centro Specialistico Odontoiatrico, Rome
- Investigators
- Marco Clementini, DDS, PhD, Principal investigator, Centro Specialistico Odontoiatrico, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367766
- Sponsor's protocol ID
- IIP/ARP/SH
- Acronym
- IIP/ARP/SH
- Status last verified
- Dec 2023
- First submitted
- 25 Apr 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results will be presented in open access publication in international peer-reviewed journal
Publications
Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
PubMed 31215112Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.
PubMed 31050359
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of the Fresh Extraction Socket in the Aesthetic Area: Alveolar Ridge Preservation vs Immediate Implant Placement vs Delayed Implant Placement
- ClinicalTrials.gov ID
- NCT04367766
- Acronym / sponsor ID
- IIP/ARP/SH / IIP/ARP/SH
- Keywords
- Immediate implant placement, alveolar ridge preservation, delayed implant placement, PROMs, implant health, volumetric analysis, tissue augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Specialistico Odontoiatrico, RomeResearch network
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 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.
After atraumatic tooth extraction and the assessment of the feasibility of immediate implant placement, patients will be randomly assigned to one of three treatment concepts:
- Immediate Implant Placement and Immediate Provisionalization
- Alveolar Ridge Preservation. After 4 months of healing an implant will be placed with simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
- Spontaneous Healing of the socket. After 4 months of healing, an implant will be placedwith simultaneous GBR and/or Soft Tissue Augmentation procedures, if needed.
In all groups, four months after implant placement, a prosthesis will be delivered. From this experimental period onward, patients will be scheduled for maintenance. Clinical, radiographic and volumetric assessment will be performed by clinicians not involved in the surgery and blind with respect to treatment assignment at 1, 3 and 5 years post loading.
Detailed description
The overall objective of this study will be to compare the three treatment modalities after tooth extraction (immediate implant placement, alveolar ridge preservation, spontaneous healing) in terms of:
- patient-related (morbidity) outcomes during surgical procedure and the first 2 weeks after the surgical procedure
- cost-effectiveness ratio (treatment time, number of surgeries, number of appointments and overall appointments time, need for bone and soft tissue augmentation, overall costs) at the time of prosthesis delivery
- volumetric bone and soft tissue changes of the site before treatment (prior to tooth extraction), 4 months after tooth extraction, 1, 3 and 5 years after final prosthesis.
- clinical, radiographic, aesthetic and patient-related (satisfaction) outcomes at the time of prosthesis delivery and 1, 3 and 5 years after final prosthesis.
- Implant Success and Survival at 1, 3 and 5 years after final prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant Placement | Active comparator | Procedure: Prosthetically driven implant placementprosthetically driven immediate implant placement (TLC implant, Straumann) with bone substitute (BioOss Collagen, Geistlich) filling the gap between the buccal socket wall and the implant surface and a collagen matrix (Fibrogide, Geistlich) positioning at the vestibular aspect to increase soft tissue volume, with immediate (non occlusal loading) prosthetic provisionalization. |
| Alveolar Ridge Preservation (ARP) + Delayed Implant Placement: | Active comparator | Procedure: Prosthetically driven implant placementARP performed with bone substitute (BioOss Collagen, Geistlich) and a collagen matrix placed to seal the socket entrance (Mucograft Seal, Geistlich). After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm |
| Spontaneous Healing + Delayed Implant Placement | Active comparator | Procedure: Prosthetically driven implant placementextraction socket will be left to heal spontaneously. After 4 months of healing a prosthetically driven implant (TLC implant, Straumann) will be placed with adjunctive GBR procedure with bone substitute (BioOss Collagen, Geistlich) and a collagen membrane (BioGide, Geistlich) if buccal bone will be < 2 mm, and soft tissue augmentation with a collagen matrix (Fibrogide, Geistlich) if soft tissue thickness will be < 2mm . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- single tooth extraction in the anterior region of the dentition (including premolars) to be extracted
- smoking no more than 10 cigarettes/day,
- periodontal health (BoP < 10%) and good plaque control (< 20%)
- absence of symptomatic periapical radiolucencies, acute abscesses at the site of extraction,
- extraction sites with less than 30% loss of one or more walls
Key exclusion criteria (4 listed)
- growing patients
- patients with autoimmune disease, uncontrolled diabetes or immunocompromised
- history of head and neck radiation for cancer treatment,
- pregnancy
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 |
|---|---|---|
| Prosthetically driven implant placementAlso: Prosthetically driven implant installationInsertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan | Procedure or surgery | Alveolar Ridge Preservation (ARP) + Delayed Implant Placement:, Immediate Implant Placement, Spontaneous Healing + Delayed Implant Placement |
Primary outcome
Rate of adjunctive bone and soft tissue augmentation procedures need.
Time frame: during implant placement
Number of participants with the need for adjunctive reconstructive hard tissue procedure during implant placement will be evaluated as a frequency (Yes/No) after a digital prosthetically driven implant placement. The need for soft tissue augmentation during implant placement will be evaluated as a frequency (Yes/No) by a blinded examiner in case of buccal soft tissue thickness < 2mm assessed at 3mm apical to the full thickness flap margin with a caliber.
1 secondary outcome
Peri-Implant Health
Time frame: 1, 3, 5 years post loading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 31215112Tonetti MS, Jung RE, Avila-Ortiz G, Blanco J, Cosyn J, Fickl S, Figuero E, Goldstein M, Graziani F, Madianos P, Molina A, Nart J, Salvi GE, Sanz-Martin I, Thoma D, Van Assche N, Vignoletti F. Management of the extraction socket and timing of implant placement: Consensus report and clinical recommendations of group 3 of the XV European Workshop in Periodontology. J Clin Periodontol. 2019 Jun;46 Suppl 21:183-194. doi: 10.1111/jcpe.13131.
- Background: PubMed 31050359Clementini M, Agostinelli A, Castelluzzo W, Cugnata F, Vignoletti F, De Sanctis M. The effect of immediate implant placement on alveolar ridge preservation compared to spontaneous healing after tooth extraction: Radiographic results of a randomized controlled clinical trial. J Clin Periodontol. 2019 Jul;46(7):776-786. doi: 10.1111/jcpe.13125. Epub 2019 May 31.
- Individual participant dataSharing planned: Yes. all IPD that underlie results will be presented in open access publication in international peer-reviewed journal
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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.
Marco Clementini, DDS, PhD principal investigator
Centro Specialistico Odontoiatrico, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetically driven implant placement in people with Tooth Extraction Status Nos and Dental Implant, run by Centro Specialistico Odontoiatrico, Rome 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 6 inclusion and 4 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Clementini, DDS, PhD (00393388378866, mclementini@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adjunctive bone and soft tissue augmentation procedures need. (time frame: during implant placement). 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 NCT04367766, which also lists 2 linked publications.
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 Dec 2023.