Bio-Oss; MucograftNCT03395145
Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss Collagen and Mucograft Seal
A study testing Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal in people with Bio-Oss; Mucograft, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bio-Oss; Mucograft
- What is being tested?
- Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 27 May 2018to 17 Jul 2022
- 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
- Written informed consent.
- Patients of 18 years or older.
- Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
- Patients who need implant placement at the site of extraction.
Who cannot join
- Inability to complete or understand the informed consent process.
- Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
- Pregnant or lactating women.
- Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- Heavy smokers (more than 10 cigarettes per day).
- Patients with removable prosthesis, which might compress the treated site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction
Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction
Read the detailed description
In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.
Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.
Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.
- Conditions
- Bio-Oss; Mucograft
- Being tested
- Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Bio-Oss® Collagen and Geistlich Mucograft® SealDevice
Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss Collagen and Mucograft Seal | Experimental | Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Receives: Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal |
| Natural healing | No intervention | Evaluation of Bone volume Changes after tooth extraction (natural healing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
socket width mm
The socket width (buccal-lingual aspect) will be assessed at the following reference points:
- 3-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.
- 5-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact.
- The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest.
- The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.
Measured: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
alveolar height mm
Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.
Measured: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
keratinized tissue mm
In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.
Measured: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start27 May 2018
- Primary completion17 Jul 2022
- Study completion17 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bio-Oss; MucograftStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Machtei, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395145
- Sponsor's protocol ID
- 0507-17-RMB CTIL
- Status last verified
- Apr 2023
- First submitted
- 1 Jan 2018
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Bone Volume Changes After Socket Preservation Using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal Compared to Natural Healing After Tooth Extraction
- ClinicalTrials.gov ID
- NCT03395145
- Acronym / sponsor ID
- 0507-17-RMB CTIL
- Conditions
- Bio-Oss; Mucograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 27 May 2018 (actual)
- Primary completion
- 17 Jul 2022 (actual)
- Study completion
- 17 Jul 2022 (actual)
- First posted
- 10 Jan 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.
Evaluation of Bone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal compared to natural healing after tooth extraction
Detailed description
In the last decade dental implants have become widely used for oral rehabilitation. But, the usage of dental Implants might be difficult in cases of alveolar bone deficiencies.
Different ridge preservation techniques were successfully used, using membrane with or without bone substitutes.new grafting material is Mucograft Seal, a collagen matrix graft, which originally used as an alternative to the connective tissue graft for the treatment of gingival recessions. Mucograft has demonstrated a good tissue reaction with high biocompatibility and a low shrinkage tendency, in order to increase the amount of keratinized gingiva in the augmented area.
Study Hypothesis: The observed changes in ridge dimensions when using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal as ridge preservation will be less pronounced in comparison to natural healing after tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss Collagen and Mucograft Seal | Experimental | Device: Geistlich Bio-Oss® Collagen and Geistlich Mucograft® SealBone volume Changes after socket preservation using Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal |
| Natural healing | No intervention | –Evaluation of Bone volume Changes after tooth extraction (natural healing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent.
- Patients of 18 years or older.
- Patients in need of a tooth extraction in the area of premolars, canines or incisors due to periodontal and/or dental reasons, provided that the socket walls are intact (bone dehiscence of max. 4mm limited to one bone wall).
- Patients who need implant placement at the site of extraction.
Key exclusion criteria (6 listed)
- Inability to complete or understand the informed consent process.
- Bone dehiscence at extraction socket of more than 4 mm or 4 mm at more than one bony wall.
- Pregnant or lactating women.
- Patients who use medications that affect bone metabolism such as IV bisphosphonates.
- Heavy smokers (more than 10 cigarettes per 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 |
|---|---|---|
| Geistlich Bio-Oss® Collagen and Geistlich Mucograft® SealGeistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction | Device | Bio-Oss Collagen and Mucograft Seal |
Primary outcome
socket width mm
Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
The socket width (buccal-lingual aspect) will be assessed at the following reference points: 1. 3-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact. 2. 5-(∆ACH pre-post) millimeters apical to the alveolar crest, where the buccal and lingual walls are intact. 3. The width of each cortical buccal and lingual bone plate, 3 millimeters apical to the alveolar crest. 4. The width of each cortical buccal and lingual bone plate, 5 millimeters apical to the alveolar crest.
alveolar height mm
Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
Alveolar crest height (ACH) will be measured from the apical part of the stent to the bone crest at the mid M-D distance of the socket.
keratinized tissue mm
Time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading
In the lower jaw the keratinized tissue width will be measured from the apical part of the stent to the mucogingival line on the buccal and lingual sides. On the upper jaw only the keratinized tissue on the buccal side will be measured.
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 4 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Bio-Oss; Mucograft
RecruitingObservational study
Mucograft Seal in ARP Follow-up
Dental Implant
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.
Eli Machtei, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal in people with Bio-Oss; Mucograft, run by Rambam Health Care Campus at 1 site in Israel.
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 4 inclusion and 6 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 4 Apr 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 Israel. 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?
socket width mm (time frame: baseline (prior to tooth extraction) and 6 months (implant placement) and at 21 month (one year after loading). The study lists 3 primary outcomes in all. 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 4 Apr 2023.