Socket SealingNCT05448040
Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting
A study testing Socket preservation in people with Socket Sealing and Free Gingival Graft, run by Universidade Salgado de Oliveira at 1 site in United States.
Trial summary
The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Socket Sealing, Free Gingival Graft, Collagen Membrane
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Nov 2021
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients ASA I
- patients requiring single tooth extraction in the site between #4 to #13
- patients without enough bone volume for immediate implant placement.
Who cannot join
- patients with general contraindications for implant surgery
- pregnant or lactating women
- patients with untreated periodontitis
- bruxism or severe clenching
- immunosuppressed
- patients with a previous history of irradiation of the head and neck area
Show all 11Show fewer
- uncontrolled diabetes
- heavy smoker (>10 cigarettes/day)
- poor oral hygiene and low motivation
- use of bisphosphonates
- substance abuse such as alcohol or drugs and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting: a Randomized Controlled Clinical Trial
The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.
- Conditions
- Socket Sealing, Free Gingival Graft, Collagen Membrane
- Being tested
- Socket preservation
- Keywords
- Alveolar sealing, Free gingival graft, Autogenous graft, Collagen matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
Tooth extraction and preservation with a biomaterial
| Study group | Role | What they receive |
|---|---|---|
| Collagen | Experimental | This group received a bone graft (xenograft) and had the socket covered with a collagen membrane, in order to protect the bone graft inserted and seal the socket. Receives: Procedure: Socket preservation |
| Free gingival graft | Experimental | This group received a bone graft (xenograft) biomaterial and had the socket covered with a free gingival graft material, in order to protect the bone graft inserted and seal the socket. Receives: Procedure: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic and clinical analysis
Socket preservation with xenograft biomaterial and another one to seal it (FGG or collagen membrane).
Radiographic analysis - PA (periapical x-rays) comparing groups and periods of the follow-up. It was performed descriptive comparative analysis.
Clinical evaluation - bleeding on probing (dichotomic analysis), ISQ (torque achieved - Osstell), qualitative analysis (questionnaire with 8 questions), and subjective appraisal of the soft tissue healing (according to the period of evaluation).
Measured: 6 months
Secondary outcomes (1)
Histological analysis - Gingiva
Gingival thickness obtained from the local tissue was evaluated through histological analysis (optical binocular microscope); assessment of the epithelial and connective layers (micrometers).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Feb 2018
- Primary completion18 Sep 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket SealingStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Salgado de Oliveira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo Fernandes, DDS, MSc, PhD, University of Michigan
- Investigators
- Joly, PhD, Principal investigator, Sao Leopoldo Mandic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448040
- Sponsor's protocol ID
- 370723 14.4.0000.5374
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05448040
- Acronym / sponsor ID
- 370723 14.4.0000.5374
- Conditions
- Socket Sealing, Free Gingival Graft, Collagen Membrane
- Keywords
- Alveolar sealing, Free gingival graft, Autogenous graft, Collagen matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Salgado de OliveiraUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 7 Jul 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.
The goal of this study was to compare, clinical and histologically, the use of the suine collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological analysis. Qualitative information related to the patient's perception considering the treatment were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagen | Experimental | Procedure: Socket preservationThis group received a bone graft (xenograft) and had the socket covered with a collagen membrane, in order to protect the bone graft inserted and seal the socket. |
| Free gingival graft | Experimental | Procedure: Socket preservationThis group received a bone graft (xenograft) biomaterial and had the socket covered with a free gingival graft material, in order to protect the bone graft inserted and seal the socket. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients ASA I
- patients requiring single tooth extraction in the site between #4 to #13
- patients without enough bone volume for immediate implant placement.
Key exclusion criteria (11 listed)
- patients with general contraindications for implant surgery
- pregnant or lactating women
- patients with untreated periodontitis
- bruxism or severe clenching
- immunosuppressed
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 |
|---|---|---|
| Socket preservationTooth extraction and preservation with a biomaterial | Procedure or surgery | Collagen, Free gingival graft |
Primary outcome
Radiographic and clinical analysis
Time frame: 6 months
Socket preservation with xenograft biomaterial and another one to seal it (FGG or collagen membrane). Radiographic analysis - PA (periapical x-rays) comparing groups and periods of the follow-up. It was performed descriptive comparative analysis. Clinical evaluation - bleeding on probing (dichotomic analysis), ISQ (torque achieved - Osstell), qualitative analysis (questionnaire with 8 questions), and subjective appraisal of the soft tissue healing (according to the period of evaluation).
1 secondary outcome
Histological analysis - Gingiva
Time frame: 6 months
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 7 Jul 2022.
- Individual participant dataSharing planned: No. No.
Related trials for Socket Sealing
Not yet recruiting
Ovate Pontic Versus Essix Provisional After Tooth Extraction and Alveolar Ridge Preservation (Pontic-Essix)
Tooth Loss / Rehabilitation, Tooth Extraction
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.
Joly, PhD principal investigator
Sao Leopoldo Mandic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation in people with Socket Sealing and Free Gingival Graft, run by Universidade Salgado de Oliveira at 1 site in United States.
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 3 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 7 Jul 2022. 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 United States. 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?
Radiographic and clinical analysis (time frame: 6 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 7 Jul 2022.