ImplantNCT03784430
Soft and Hard Tissue Changes After Immediate Single-tooth Replacement
A study testing Immediate dental implant placement and Immediate dental implant placement with CTG in people with Implant, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant
- What is being tested?
- Immediate dental implant placement and Immediate dental implant placement with CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2017to 9 Jun 2021
- 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
- a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar
- patient in good systemic health, with no contraindication for oral surgical interventions
Who cannot join
- patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes)
- assumption of bisphosphonate
- smoking more than 10 cigarettes a day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft
A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).
Read the detailed description
All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.
- Conditions
- Implant
- Being tested
- Immediate dental implant placement, Immediate dental implant placement with CTG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implant placementProcedure or surgery
Tooth will be extracted and a dental implant will be positioned at the same time.
Immediate dental implant placement with CTGProcedure or surgery
Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| Implant | Active comparator | Immediate dental implant placement Receives: Procedure: Immediate dental implant placement |
| Implant+CTG | Experimental | Immediate dental implant placement with CTG. Receives: Procedure: Immediate dental implant placement with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric buccal bone changes
Ratio scale - lower values represent a better outcome
Measured: 6 months
Secondary outcomes (3)
Volumetric buccal soft tissue changes
Ratio scale - higher values represent a better outcome
Measured: 6 months
Buccal soft tissue changes
Ratio scale - higher values represent a better outcome
Measured: 6 months
Patient perception outcomes
Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'
Measured: 1 week and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start3 Oct 2017
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo de Sanctis, Università Vita-Salute San Raffaele
- Investigators
- Massimo de Sanctis, MD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784430
- Sponsor's protocol ID
- Winsix 1
- Status last verified
- May 2022
- First submitted
- 19 Dec 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider D, Schmidlin PR, Philipp A, Annen BM, Ronay V, Hammerle CH, Attin T, Jung RE. Labial soft tissue volume evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2014 Jun;41(6):612-7. doi: 10.1111/jcpe.12246. Epub 2014 Mar 26.
PubMed 24593810Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PubMed 23163915Chappuis V, Bornstein MM, Buser D, Belser U. Influence of implant neck design on facial bone crest dimensions in the esthetic zone analyzed by cone beam CT: a comparative study with a 5-to-9-year follow-up. Clin Oral Implants Res. 2016 Sep;27(9):1055-64. doi: 10.1111/clr.12692. Epub 2015 Sep 15.
PubMed 26370904Schropp L, Wenzel A, Spin-Neto R, Stavropoulos A. Fate of the buccal bone at implants placed early, delayed, or late after tooth extraction analyzed by cone beam CT: 10-year results from a randomized, controlled, clinical study. Clin Oral Implants Res. 2015 May;26(5):492-500. doi: 10.1111/clr.12424. Epub 2014 Jun 2.
PubMed 24890861
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft
- ClinicalTrials.gov ID
- NCT03784430
- Acronym / sponsor ID
- Winsix 1
- Conditions
- Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 21 Dec 2018 (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.
A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft concurrent with immediate implantation may contribute to the stability of gingival level and the augmentation of soft tissue contour. However, most included studies did not have a control group to directly demonstrate the benefit of an immediate implant combined with soft tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized controlled clinical trial with a parallel design is to evaluate the influence of the connective tissue graft on the buccal bone alterations after tooth extraction and immediate implant placement by means of cone beam computer tomography (CBCT).
Detailed description
All participants will be selected on a consecutive basis, among individuals, above the age of 18 years, referred to Dental Clinic of the San Raffaele University, with a single failing tooth in the upper and lower jaw from second premolar to second premolar, candidates for a single implant restoration. After local anesthesia, a split-full-split thickness envelope flap, as described for the treatment of multiple gingival recessions by Zucchelli and de Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The immediate implantation procedure will be carried out according to the manufacture protocol and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the extraoral de-epithelialization with the knife blade of a free gingival graft harvested from the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the buccal crest. Patients will be followed for 6 months after implant placement and 6 months after loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant | Active comparator | Procedure: Immediate dental implant placementImmediate dental implant placement |
| Implant+CTG | Experimental | Procedure: Immediate dental implant placement with CTGImmediate dental implant placement with CTG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a single tooth to be extracted for endodontic failure, fractures, root caries or resorption in the maxillary and mandibular area from second premolar to second premolar
- patient in good systemic health, with no contraindication for oral surgical interventions
Key exclusion criteria (3 listed)
- patients with impaired systemic diseases that will interfere with surgical interventions (autoimmune diseases, uncontrolled diabetes)
- assumption of bisphosphonate
- smoking more than 10 cigarettes a day
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 implant placementTooth will be extracted and a dental implant will be positioned at the same time. | Procedure or surgery | Implant |
| Immediate dental implant placement with CTGTooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft. | Procedure or surgery | Implant+CTG |
Primary outcome
Volumetric buccal bone changes
Time frame: 6 months
Ratio scale - lower values represent a better outcome
3 secondary outcomes
Volumetric buccal soft tissue changes
Time frame: 6 months
Buccal soft tissue changes
Time frame: 6 months
Patient perception outcomes
Time frame: 1 week and 6 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 17 May 2022.
- Background: PubMed 24593810Schneider D, Schmidlin PR, Philipp A, Annen BM, Ronay V, Hammerle CH, Attin T, Jung RE. Labial soft tissue volume evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2014 Jun;41(6):612-7. doi: 10.1111/jcpe.12246. Epub 2014 Mar 26.
- Background: PubMed 23163915Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
- Background: PubMed 26370904Chappuis V, Bornstein MM, Buser D, Belser U. Influence of implant neck design on facial bone crest dimensions in the esthetic zone analyzed by cone beam CT: a comparative study with a 5-to-9-year follow-up. Clin Oral Implants Res. 2016 Sep;27(9):1055-64. doi: 10.1111/clr.12692. Epub 2015 Sep 15.
- Background: PubMed 24890861Schropp L, Wenzel A, Spin-Neto R, Stavropoulos A. Fate of the buccal bone at implants placed early, delayed, or late after tooth extraction analyzed by cone beam CT: 10-year results from a randomized, controlled, clinical study. Clin Oral Implants Res. 2015 May;26(5):492-500. doi: 10.1111/clr.12424. Epub 2014 Jun 2.
- 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.
Massimo de Sanctis, MD principal investigator
Università Vita-Salute San Raffaele
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 implant placement and Immediate dental implant placement with CTG in people with Implant, run by Università Vita-Salute San Raffaele 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 2 inclusion and 3 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 17 May 2022. 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?
Volumetric buccal bone changes (time frame: 6 months). 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 NCT03784430, which also lists 4 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 17 May 2022.