Alveolar Bone LossDERMANCT03358667
Increase of Peri-implant Soft Tissues With Screw or Membrane
An observational study of Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- augmentation peri-implant soft tissue
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to 25 Mar 2021
- Phase
- Observational
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: thin peri-implant biotype; one implant for one patient
Who may be able to join
- indications for implant insertion into the posterior mandible based on careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 7 mm and a thickness of at least 6 mm at the programmed implant sites;
- the bone crest must be cured (at least 6 months after the loss / extraction of the corresponding dental element);
- Soft tissue height above the implant ≤ 2mm;
- no regenerated bone;
- Plaque index below 25% and bleeding index less than 20%;
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- buco-lingual amplitude of the adherent gingiva ≥ 4 mm;
- age of the patient> 18 years;
- patients should be able to examine and understand the study protocol;
- informed consent.
Who cannot join
- acute myocardial infarction in the last 2 months;
- uncompensated coagulation turbines;
- unmanaged diabetes (HbA1c> 7.5%);
- head / neck district radiotherapy for the last 24 months;
- immunocompromised patients (HIV infection or chemotherapy over the last 5 years);
- present or past treatment with intravenous bisphosphonates;
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- psychological or psychiatric problems;
- abuse of alcohol and / or drugs;
- smokers
- 11) non-controlled periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Dermal Matrix Membrane and Tent-screw Technique for Vertical Increase of Peri-implant Soft Tissues
The objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant.
Read the detailed description
The presence of soft tissue over the implants plays an important role both in bone preservation and in enhancing aesthetic conditions. The importance of good quality and amount of soft tissues was indicated by colleagues in 1994: the soft tissue enhancement technique involved inserting, at the site of the implant, a connective tissue graft taken from the palate of the patient itself. The technique was intended to allow a better aesthetic result in the treated area and to prevent metal exposure in case of reabsorption of the vestibular bone. In a systematic review of literature, some authors in 2014 have shown that a soft tissue graft applied to the implant placement area will provide a better aesthetic result. Colleagues in 2010 tested the increase in thickness of peri-implant tissues in a randomized and controlled split-mouth study: at the time of implant placement, a site received a connective plug and one received no graft. The average thickness increase in the grafted sites was 1.3 mm and allowed for aesthetic improvement.
In recent years, some human or animal origin materials have been introduced to replace the connective tissue which, being taken by the patient, often binds to a second surgical area with increased morbidity, postoperative discomfort and longer duration of intervention same. The use of deproteinized human dermis was first introduced in plastic surgery in 1995 and ophthalmic in 1999 in the second half of the 90s and then in oral surgery. Recently colleagues used the deproteinized dermis of human origin, placed at the same time as the implants, to evaluate whether the thickening of peri-implant tissues reduced marginal bone resorption after prosthetic loading. Their study showed that areas receiving an insertion had a reduced marginal bone resorption compared to areas with thin soft tissues, without quantifying the increase in soft tissues. In another prospective study, Lorenzo and colleagues in 2011 compared the connective tissue taken from the palate to a dermal matrix of porcine origin to obtain an increase in keratinized tissue bandage: the two techniques yielded similar results. Even in this case, however, the vertical thickness increase of soft tissues was not evaluated.
- Conditions
- Alveolar Bone Loss
- Being tested
- augmentation peri-implant soft tissue
- Keywords
- peri-implant soft tissue augmentation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
augmentation peri-implant soft tissueProcedure or surgery
the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion
| Study group | Role | What they receive |
|---|---|---|
| group A | single edentulism implant insertion tent screw 2mm augmentation peri-implant soft tissue Receives: Procedure: augmentation peri-implant soft tissue | |
| group B | single edentulism implant insertion cover screw and membrane augmentation peri-implant soft tissue Receives: Procedure: augmentation peri-implant soft tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue width
measurement of the full thickness flap
Measured: 6 months after surgery
Secondary outcomes (1)
implant survival rate
percentage of implant functional effective
Measured: two years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Oct 2019
- Study completion25 Mar 2021
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 Alveolar Bone LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr, Principal investigator, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358667
- Sponsor's protocol ID
- DERMA
- Acronym
- DERMA
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2017
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puisys A, Vindasiute E, Linkevciene L, Linkevicius T. The use of acellular dermal matrix membrane for vertical soft tissue augmentation during submerged implant placement: a case series. Clin Oral Implants Res. 2015 Apr;26(4):465-470. doi: 10.1111/clr.12401. Epub 2014 Apr 30.
PubMed 24779749Suarez-Lopez Del Amo F, Lin GH, Monje A, Galindo-Moreno P, Wang HL. Influence of Soft Tissue Thickness on Peri-Implant Marginal Bone Loss: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jun;87(6):690-9. doi: 10.1902/jop.2016.150571. Epub 2016 Jan 16.
PubMed 26777766
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dermal Matrix Membrane and Tent-screw Technique for Vertical Increase of Peri-implant Soft Tissues
- ClinicalTrials.gov ID
- NCT03358667
- Acronym / sponsor ID
- DERMA / DERMA
- Conditions
- Alveolar Bone Loss
- Keywords
- peri-implant soft tissue augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 30 Nov 2017 (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 objective of this observational study is to evaluate the growth of peri-implant soft tissues using an heterologous dermal membrane graft (group A) or a 2 mm healing screw used as a vertical support of the limbs (group B) positioned at the moment of surgical insertion of the implant.
Detailed description
The presence of soft tissue over the implants plays an important role both in bone preservation and in enhancing aesthetic conditions. The importance of good quality and amount of soft tissues was indicated by colleagues in 1994: the soft tissue enhancement technique involved inserting, at the site of the implant, a connective tissue graft taken from the palate of the patient itself. The technique was intended to allow a better aesthetic result in the treated area and to prevent metal exposure in case of reabsorption of the vestibular bone. In a systematic review of literature, some authors in 2014 have shown that a soft tissue graft applied to the implant placement area will provide a better aesthetic result. Colleagues in 2010 tested the increase in thickness of peri-implant tissues in a randomized and controlled split-mouth study: at the time of implant placement, a site received a connective plug and one received no graft. The average thickness increase in the grafted sites was 1.3 mm and allowed for aesthetic improvement.
In recent years, some human or animal origin materials have been introduced to replace the connective tissue which, being taken by the patient, often binds to a second surgical area with increased morbidity, postoperative discomfort and longer duration of intervention same. The use of deproteinized human dermis was first introduced in plastic surgery in 1995 and ophthalmic in 1999 in the second half of the 90s and then in oral surgery. Recently colleagues used the deproteinized dermis of human origin, placed at the same time as the implants, to evaluate whether the thickening of peri-implant tissues reduced marginal bone resorption after prosthetic loading. Their study showed that areas receiving an insertion had a reduced marginal bone resorption compared to areas with thin soft tissues, without quantifying the increase in soft tissues. In another prospective study, Lorenzo and colleagues in 2011 compared the connective tissue taken from the palate to a dermal matrix of porcine origin to obtain an increase in keratinized tissue bandage: the two techniques yielded similar results. Even in this case, however, the vertical thickness increase of soft tissues was not evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Procedure: augmentation peri-implant soft tissuesingle edentulism implant insertion tent screw 2mm augmentation peri-implant soft tissue |
| group B | – | Procedure: augmentation peri-implant soft tissuesingle edentulism implant insertion cover screw and membrane augmentation peri-implant soft tissue |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- thin peri-implant biotype; one implant for one patient
Key inclusion criteria (10 listed)
- indications for implant insertion into the posterior mandible based on careful diagnosis and treatment plan;
- presence of a residual bone crest with a minimum surgical height of 7 mm and a thickness of at least 6 mm at the programmed implant sites;
- the bone crest must be cured (at least 6 months after the loss / extraction of the corresponding dental element);
- Soft tissue height above the implant ≤ 2mm;
- no regenerated bone;
Key exclusion criteria (10 listed)
- acute myocardial infarction in the last 2 months;
- uncompensated coagulation turbines;
- unmanaged diabetes (HbA1c> 7.5%);
- head / neck district radiotherapy for the last 24 months;
- immunocompromised patients (HIV infection or chemotherapy over the last 5 years);
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 peri-implant soft tissuethe implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion | Procedure or surgery | group A, group B |
Primary outcome
soft tissue width
Time frame: 6 months after surgery
measurement of the full thickness flap
1 secondary outcome
implant survival rate
Time frame: two years from surgery
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 26 Mar 2021.
- Background: PubMed 24779749Puisys A, Vindasiute E, Linkevciene L, Linkevicius T. The use of acellular dermal matrix membrane for vertical soft tissue augmentation during submerged implant placement: a case series. Clin Oral Implants Res. 2015 Apr;26(4):465-470. doi: 10.1111/clr.12401. Epub 2014 Apr 30.
- Background: PubMed 26777766Suarez-Lopez Del Amo F, Lin GH, Monje A, Galindo-Moreno P, Wang HL. Influence of Soft Tissue Thickness on Peri-Implant Marginal Bone Loss: A Systematic Review and Meta-Analysis. J Periodontol. 2016 Jun;87(6):690-9. doi: 10.1902/jop.2016.150571. Epub 2016 Jan 16.
- 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.
Claudio Stacchi, Dr principal investigator
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Loss, run by International Piezosurgery Academy 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 10 inclusion and 10 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 26 Mar 2021. 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?
soft tissue width (time frame: 6 months after 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 NCT03358667, 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 26 Mar 2021.