Tooth LossNCT02356770
A Clinical Study to Investigate Collagen Matrix 10808 for Soft Tissue Volume Augmentation Around Single Implants
A study testing Collagen Matrix 10808 and Connective tissue graft in people with Tooth Loss and Soft Tissue Deficiency, run by Geistlich Pharma AG at 1 site in Switzerland.
Trial summary
The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Soft Tissue Deficiency
- What is being tested?
- Collagen Matrix 10808 and 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
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2012to Jul 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implant placement at least 6 weeks and maximum 6 months prior enrolment
- Necessity of soft tissue augmentation in single tooth gap
- 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
- Basic periodontal examination (BPE <2)
- 18 years or older
- Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
Who cannot join
- Heavy smoker (> 10 cigarettes per day)
- Probing depth greater than 4 mm
- Insulin dependent diabetes
- General contraindications for dental and/or surgical treatment
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
- Women of child bearing age, not using a standard accepted method of birth control
Show all 11Show fewer
- Pregnancy or breast feeding
- Previous and concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
- Disease affecting connective tissue metabolism (e.g. collagenases).
- Allergy to collagen
- Participation in a clinical trial within the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Study to Investigate Effectiveness and Safety of a Collagen Matrix 10808 for Soft Tissue Volume Augmentation After Implant Placement in Single Tooth Gaps
The objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.
Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.
Read the detailed description
The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.
- Conditions
- Tooth Loss, Soft Tissue Deficiency
- Being tested
- Collagen Matrix 10808, Connective tissue graft
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen Matrix 10808Device
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
Connective tissue graftProcedure or surgery
At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
| Study group | Role | What they receive |
|---|---|---|
| Collagen Matrix 10808 | Experimental | Mucosal split-thickness flap in combination with the Collagen Matrix 10808. Receives: Device: Collagen Matrix 10808 |
| Connective tissue graft (gold standard) | Other | Mucosal split-thickness flap in combination with the connective tissue graft. Receives: Procedure: Connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Measured: at day 90 compared to day 0 (Baseline)
Secondary outcomes (16)
Assessment of Adverse Events
Measured: from Day 0 to Day 90
Closure of the wound
Measured: at Day 7, 30, 90
Presence of Swelling
Measured: at Day 7, 30, 90
Oral health impact profile (OHIP-G14) score
Measured: at day 0, 7, 90
Daily Mefenaminacid consumption
Measured: between Day 0 and Day 7
Evaluation of pain using a VAS(Visual Analogue Scale) score daily
Measured: between Day 0 and day 7 and at Day 30 and 90
Surgery time
Measured: at surgery
Qualitative histological assessment regarding matrix degradation and safety parameters
Measured: at day 90
Gain in mucosal soft tissue thickness by 3D volumetric analysis
Measured: at day 90, compared to day 0
Gain in mucosal soft tissue thickness measured by trans-mucosal probing
Measured: at day 30 compared to day 0
Keratinized Tissue width (mm)
Measured: at day 0 and at day 90
Probing Depth (mm)
Measured: at day 0 and at day 90
Clinical Attachment Level (mm)
Measured: at day 0 and at day 90
Bleeding of Probing (0/1)
Measured: at day 0 and at day 90
Plaque Index (0-3)
Measured: at day 0 and at day 90
Recession depth (mm)
Measured: at day 0 and at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenz Uebersax, PhD, Study director, Geistlich Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356770
- Sponsor's protocol ID
- 10860
- Other IDs
- DRKS00003586, CIV-11-12-003323
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2014
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study to Investigate Effectiveness and Safety of a Collagen Matrix 10808 for Soft Tissue Volume Augmentation After Implant Placement in Single Tooth Gaps
- ClinicalTrials.gov ID
- NCT02356770
- Acronym / sponsor ID
- 10860
- Conditions
- Tooth Loss, Soft Tissue Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Feb 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 objective of this study is to investigate the safety and the function of the collagen Matrix 10808 in humans and to compare it versus the standard therapy, the transplantation of the autologous connective tissue graft. The Collagen Matrix was developed for soft tissue augmentation. It is a three dimensional porous Matrix and consists mainly of Collagen I and III.
Study patients must have a single tooth gap with insufficient soft tissue volume after implant placement. Therefore a soft tissue augmentation will be necessary.
Detailed description
The primary objective of this study is to assess the effectiveness of soft tissue volume augmentation procedures using the autogenous soft tissue graft or the Collagen Matrix 10808 to gain mucosal thickness. Second the safety of the two procedures will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen Matrix 10808 | Experimental | Device: Collagen Matrix 10808Mucosal split-thickness flap in combination with the Collagen Matrix 10808. |
| Connective tissue graft (gold standard) | Other | Procedure: Connective tissue graftMucosal split-thickness flap in combination with the connective tissue graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Implant placement at least 6 weeks and maximum 6 months prior enrolment
- Necessity of soft tissue augmentation in single tooth gap
- 2 teeth adjacent to each side of the defect have a mean BOP (Bleeding of probing) of < 30%
- Basic periodontal examination (BPE <2)
- 18 years or older
Key exclusion criteria (11 listed)
- Heavy smoker (> 10 cigarettes per day)
- Probing depth greater than 4 mm
- Insulin dependent diabetes
- General contraindications for dental and/or surgical treatment
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five 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 |
|---|---|---|
| Collagen Matrix 10808At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound. | Device | Collagen Matrix 10808 |
| Connective tissue graftAt the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound. | Procedure or surgery | Connective tissue graft (gold standard) |
Primary outcome
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing
Time frame: at day 90 compared to day 0 (Baseline)
16 secondary outcomes
Assessment of Adverse Events
Time frame: from Day 0 to Day 90
Closure of the wound
Time frame: at Day 7, 30, 90
Presence of Swelling
Time frame: at Day 7, 30, 90
Oral health impact profile (OHIP-G14) score
Time frame: at day 0, 7, 90
Daily Mefenaminacid consumption
Time frame: between Day 0 and Day 7
Evaluation of pain using a VAS(Visual Analogue Scale) score daily
Time frame: between Day 0 and day 7 and at Day 30 and 90
Surgery time
Time frame: at surgery
Qualitative histological assessment regarding matrix degradation and safety parameters
Time frame: at day 90
Gain in mucosal soft tissue thickness by 3D volumetric analysis
Time frame: at day 90, compared to day 0
Gain in mucosal soft tissue thickness measured by trans-mucosal probing
Time frame: at day 30 compared to day 0
Keratinized Tissue width (mm)
Time frame: at day 0 and at day 90
Probing Depth (mm)
Time frame: at day 0 and at day 90
Clinical Attachment Level (mm)
Time frame: at day 0 and at day 90
Bleeding of Probing (0/1)
Time frame: at day 0 and at day 90
Plaque Index (0-3)
Time frame: at day 0 and at day 90
Recession depth (mm)
Time frame: at day 0 and at day 90
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 25 Feb 2019.
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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.
Lorenz Uebersax, PhD study director
Geistlich Pharma AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Matrix 10808 and Connective tissue graft in people with Tooth Loss and Soft Tissue Deficiency, run by Geistlich Pharma AG at 1 site in Switzerland.
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 7 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 25 Feb 2019. 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 Switzerland. 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?
Gain in mucosal soft tissue thickness at day 90 compared to day 0 (Baseline) value measured by trans-mucosal probing (time frame: at day 90 compared to day 0 (Baseline)). 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 25 Feb 2019.