Oral Soft Tissue ConditionsPhase 2NCT02513368
Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques
A Phase 2 study testing augmentation procedure with Bio-Oss® and Bio-Gide® and augmentation procedure with connective tissue graft in people with Oral Soft Tissue Conditions, run by University of Firenze and Siena, Napoli, Italy at 2 sites in Italy.
Trial summary
The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Soft Tissue Conditions
- What is being tested?
- augmentation procedure with Bio-Oss® and Bio-Gide® and augmentation procedure with connective tissue graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2011to Mar 2014
- Phase
- Phase 2
- 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
- one missing tooth in the anterior maxilla
- facial keratinized mucosa thickness of at least 2mm
Who cannot join
- heavy smokers
- systemic diseases
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, Siena, 53100
Tuscan School of Dentistry
Siena, Siena, 53100
About this study
Official title: Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft
The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .
Read the detailed description
With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.
- Conditions
- Oral Soft Tissue Conditions
- Being tested
- augmentation procedure with Bio-Oss® and Bio-Gide®, augmentation procedure with connective tissue graft
- Keywords
- aesthetic, connective tissue graft, mucosa thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmentation procedure with Bio-Oss® and Bio-Gide®Device
soft tissue management using GBR procedure
augmentation procedure with connective tissue graftProcedure or surgery
soft tissue management using the bilaminar technique
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss®, Bio-Gide® | Experimental | augmentation procedure with Bio-Oss® and Bio-Gide® Receives: Device: augmentation procedure with Bio-Oss® and Bio-Gide® |
| connective tissue graft | Active comparator | augmentation procedure with connective tissue graft Receives: Procedure: augmentation procedure with connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in the clinical characteristics of the peri implant mucosa
Buccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest
Measured: one month and one year after the placement of the definitive crowns
Secondary outcomes (2)
Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probe
Measured: one month and one year after the placement of the definitive crowns
change from baseline in height of keratinised tissue recorded at both mesial and distal tooth , adjacent to the implant site , by means of a periodontal probe
Measured: one month and one year after the placement of the definitive crowns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionMar 2014
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 Oral Soft Tissue ConditionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Firenze and Siena, Napoli, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nicola baldini, University of Firenze and Siena, Napoli, Italy
- Investigators
- massimo de sanctis, dentist, Principal investigator, school of dentale medicine , university of siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513368
- Sponsor's protocol ID
- PHSIR
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
PubMed 23347346
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri Implant Soft Tissue Healing in Single Implant Restoration Using the Guided Bone Regeneration Technique Ore a Connective Tissue Graft
- ClinicalTrials.gov ID
- NCT02513368
- Acronym / sponsor ID
- PHSIR
- Conditions
- Oral Soft Tissue Conditions
- Keywords
- aesthetic, connective tissue graft, mucosa thickness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Firenze and Siena, Napoli, ItalyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Jul 2015 (estimated)
- 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 the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .
Detailed description
With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss®, Bio-Gide® | Experimental | Device: augmentation procedure with Bio-Oss® and Bio-Gide®augmentation procedure with Bio-Oss® and Bio-Gide® |
| connective tissue graft | Active comparator | Procedure: augmentation procedure with connective tissue graftaugmentation procedure with connective tissue graft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- one missing tooth in the anterior maxilla
- facial keratinized mucosa thickness of at least 2mm
Key exclusion criteria (2 listed)
- heavy smokers
- systemic diseases
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 |
|---|---|---|
| augmentation procedure with Bio-Oss® and Bio-Gide®soft tissue management using GBR procedure | Device | Bio-Oss®, Bio-Gide® |
| augmentation procedure with connective tissue graftsoft tissue management using the bilaminar technique | Procedure or surgery | connective tissue graft |
Primary outcome
change from baseline in the clinical characteristics of the peri implant mucosa
Time frame: one month and one year after the placement of the definitive crowns
Buccal mucosa thickness was assessed with a calibrated endodontic file, 2 mm apical to the bone crest
2 secondary outcomes
Change from baseline in probing pocket depth recorded at both mesial and distal tooth , adjacent to the implant site, by means of a periodontal probe
Time frame: one month and one year after the placement of the definitive crowns
change from baseline in height of keratinised tissue recorded at both mesial and distal tooth , adjacent to the implant site , by means of a periodontal probe
Time frame: one month and one year after the placement of the definitive crowns
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 31 Jul 2015.
- Background: PubMed 23347346Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
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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, dentist principal investigator
school of dentale medicine , university of siena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing augmentation procedure with Bio-Oss® and Bio-Gide® and augmentation procedure with connective tissue graft in people with Oral Soft Tissue Conditions, run by University of Firenze and Siena, Napoli, Italy at 2 sites 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 2 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline in the clinical characteristics of the peri implant mucosa (time frame: one month and one year after the placement of the definitive crowns). 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 NCT02513368, 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 31 Jul 2015.