Changes in Soft Tissue HeightNCT05423535
Hemostatic Gelatin Sponge Versus Collagen Matrix in Alveolar Ridge Preservation
A study testing test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) in people with Changes in Soft Tissue Height, run by University Ghent at 2 sites in Belgium.
Trial summary
Patients in need of extraction of two teeth followed by implant replacement, with > 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Changes in Soft Tissue Height
- What is being tested?
- test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- 6 Mar 2022to 31 Mar 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good oral hygiene (plaque score < 25%)
- 1 or 2 neighbouring teeth present
- in need for extraction of two teeth, followed by implant placement
- >50% bone present
- signed informed consent
Who cannot join
- systematic diseases
- smoking
- history of periodontitis
- untreated caries lesions
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
BV Paro Glibert
Geraardsbergen, Oost-Vlaanderen, 9570
Centrum voor Parodontologie en Orale Implantologie
Zottegem, Oost-Vlaanderen, 9620
About this study
Official title: A Randomized Controlled Trial Comparing Hemostatic Gelatin Sponge to Collagen Matrix as Socket Seal in Alveolar Ridge Preservation
Patients in need of extraction of two teeth followed by implant replacement, with > 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge preservation.
The sample size calculation indicated 16 patients to be included per group. To compensate for dropouts, this number was increased to 20 patients per group. Coincidence (coin flip) determined which site is treated with the gelatine sponge and which with the collagen matrix.
Read more
Teeth were extracted without flap elevation. When deemed necessary by the clinician, papillary incisions were made for minimal reflection, which enabled to place elevators without damaging soft tissues. Buccal soft tissues were never raised. Following wound debridement and rinsing, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
Changes in soft tissue height at the buccal and oral aspect is the primary outcome. A small-field low-dose CBCT image was taken at T0 (immediately postop) and T3 (4 months). Those images were superimposed in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
Secondary outcomes included wound healing and closure in the first three weeks, changes in hard and soft tissues and mucosal scarring after 4 months.
- Conditions
- Changes in Soft Tissue Height
- Being tested
- test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)Device
Also called control group: gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS)
Following tooth extraction and wound debridement, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Collagen Matrix | Active comparator | collagen matrix: Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland Receives: Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) |
| Test group: Hemostatic Gelatin Sponge | Experimental | Hemostatic gelatin spons: Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS Receives: Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in soft tissue height at the buccal and lingual aspect
A CBCT was taken at T0 (immediately post-op) and T3 (4 months). Since soft tissues were separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
Measured: T0 (immediately post-op) and T3 (4 months)
Secondary outcomes (4)
Wound healing
Socket wound healing score (SWHS). SWHS was assessed on the basis of occlusal clinical pictures and results in the following scores: 0 = Wound covered with keratinized gingiva, pink tissue color, no bleeding, continuous with healthy tissue; 1 = Socket filled with organized granulation tissue, no bleeding, collapsed to a depth of 0 - 2 mm from the buccal gingival margin; 2 = Socket filled with organized granulation tissue, ¼ to ½ of the wound showing red tissue color, no bleeding, collapsed to a depth of 2 - 4 mm from the buccal gingival margin; 3 = Socket filled with unorganized granulation tissue, more than ½ of the wound showing red tissue color, bleeding, no evidence of acute infection; 4 = Socket is filled with foreign material (food, etc.) and shows signs of alveolitis.
The higher the score, the worser the outcome.
Measured: T1 (1 week), T2 (3 weeks) and T3 (4 months)
Wound dimension
Bucco-lingual and mesio-distal wound dimensions were registered with a periodontal probe to the nearest 0.5 mm at T0 (immediately postop), T1 (1 week) and T3 (4 months).
Measured: T0 (immediately post-op), T1 (1 week) and T3 (4 months)
Changes in buccal soft tissue profile
An intra-oral scan was taken at T0 (immediately postop) and T3 (4 months). The obtained digital surface models in STL format were imported into designated software to analyze profilometric changes. A study-relevant area of interest (AOI) at the buccal aspect was selected for each site. The AOI varied between sites due to individual anatomic differences but was kept constant in each site across timepoints. Digital surface models were superimposing using the best-fit algorithm at the unchanged adjacent tooth surfaces. A mean volumetric change (mm3) within the AOI for each site from T0 to T3 was calculated by the software and divided by the AOI resulting in a mean change in buccal soft tissue profile. Details on the method can be found in an earlier paper (Eeckhout et al., 2020).
Measured: T0 (immediately post-op) and T3 (4 months)
Mucosal scarring
The Mucosal Scarring Index (MSI) (Wessels et al., 2019) was registered on the basis of frontal and occlusal clinical pictures. The MSI results in a score from 0 (no scar) to 10 (most extreme scar).
The higher the score, the worser the outcome.
Measured: T3 (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start6 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: No participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Soft Tissue HeightStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Model description
- Intra-subject RCT with 2 treatment arms (control group: collagen matrix; test group: hemostatic gelatine sponge). In every patient two teeth are extracted. Coincidence (coin flip) will determine which site is treated with the gelatine sponge and which with the collagen matrix.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Cosyn, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423535
- Sponsor's protocol ID
- BC-11345
- Status last verified
- Apr 2023
- First submitted
- 3 Jun 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Hemostatic Gelatin Sponge to Collagen Matrix as Socket Seal in Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT05423535
- Acronym / sponsor ID
- BC-11345
- Conditions
- Changes in Soft Tissue Height
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 21 Jun 2022 (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.
Patients in need of extraction of two teeth followed by implant replacement, with > 50% buccal bone present following tooth extraction and with 1 or 2 neighbouring teeth present, were invited to participate in an intra-subject RCT comparing hemostatic gelatin sponge to collagen matrix as socket seal in alveolar ridge preservation.
The sample size calculation indicated 16 patients to be included per group. To compensate for dropouts, this number was increased to 20 patients per group. Coincidence (coin flip) determined which site is treated with the gelatine sponge and which with the collagen matrix.
Teeth were extracted without flap elevation. When deemed necessary by the clinician, papillary incisions were made for minimal reflection, which enabled to place elevators without damaging soft tissues. Buccal soft tissues were never raised. Following wound debridement and rinsing, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM.
Changes in soft tissue height at the buccal and oral aspect is the primary outcome. A small-field low-dose CBCT image was taken at T0 (immediately postop) and T3 (4 months). Those images were superimposed in specialized software (OnDemand3D, Cybermed Inc., Seoul, South-Korea). Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
Secondary outcomes included wound healing and closure in the first three weeks, changes in hard and soft tissues and mucosal scarring after 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-subject RCT with 2 treatment arms (control group: collagen matrix; test group: hemostatic gelatine sponge). In every patient two teeth are extracted. Coincidence (coin flip) will determine which site is treated with the gelatine sponge and which with the collagen matrix.
| Arm | Type | Receives |
|---|---|---|
| Control group: Collagen Matrix | Active comparator | Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)collagen matrix: Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland |
| Test group: Hemostatic Gelatin Sponge | Experimental | Device: test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)Hemostatic gelatin spons: Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- good oral hygiene (plaque score < 25%)
- 1 or 2 neighbouring teeth present
- in need for extraction of two teeth, followed by implant placement
- >50% bone present
- signed informed consent
Key exclusion criteria (5 listed)
- systematic diseases
- smoking
- history of periodontitis
- untreated caries lesions
- pregnancy
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 |
|---|---|---|
| test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland)Also: control group: gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson & Johnson, New Brunswick, VS)Following tooth extraction and wound debridement, the alveolar socket was filled with collagen-enriched deproteinized bovine bone mineral (C-DBBM, Bio-Oss Collagen® 100 mg or 250 mg, Geistlich Pharma AG, Wolhusen, Switzerland) up to the level of the oral bone crest. Subsequently, a collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) or gelatin spons (Spongostan Dental® 1x1x1 cm, Ethicon, Johnson \& Johnson, New Brunswick, VS) was sutured on top with 4 to 6 single sutures (Seralon 6/0, Serag Weissner, Naila, Germany) to protect the underlying C-DBBM. | Device | Control group: Collagen Matrix, Test group: Hemostatic Gelatin Sponge |
Primary outcome
Changes in soft tissue height at the buccal and lingual aspect
Time frame: T0 (immediately post-op) and T3 (4 months)
A CBCT was taken at T0 (immediately post-op) and T3 (4 months). Since soft tissues were separated from hard tissues by using lip retractors and a backward position of the tongue, soft tissue height could be assessed on CBCT images. Changes in soft tissue height were calculated by subtracting soft tissue height at T3 from soft tissue height at T0.
4 secondary outcomes
Wound healing
Time frame: T1 (1 week), T2 (3 weeks) and T3 (4 months)
Wound dimension
Time frame: T0 (immediately post-op), T1 (1 week) and T3 (4 months)
Changes in buccal soft tissue profile
Time frame: T0 (immediately post-op) and T3 (4 months)
Mucosal scarring
Time frame: T3 (4 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
Jan Cosyn, Professor principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test group: collagen matrix (Mucograft Seal®, Geistlich Pharma AG, Wolhusen, Switzerland) in people with Changes in Soft Tissue Height, run by University Ghent at 2 sites in Belgium.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 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 2 sites in Belgium. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in soft tissue height at the buccal and lingual aspect (time frame: T0 (immediately post-op) and T3 (4 months)). 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 10 Apr 2023.