Recession, GingivalNCT05961566
Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
A study testing Use of collagen matrix after subepithelial connective tissue graft harvest in people with Recession, Gingival, run by Hailey Bivens at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- Use of collagen matrix after subepithelial connective tissue graft harvest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Mar 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demographic
- Age: 18-65 years old
- Gender: Any
- Race: Any
- Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years
- Medical History
Show all 17Show fewer
- Physically and mentally healthy with no contraindications for periodontal surgery
- American Society of Anesthesiologists: ASA-I or ASA-II
- Dental history
- Periodontally healthy
- No history of surgical interventions in the palate
- No history of cleft lip/palate
- No history of orthodontic treatment involving the palate (palatal expansion).
- Other
- Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.
- Patients who are able and willing to provide informed consent
- Patients who are able and willing to follow study appointments
Who cannot join
- i. Medical History
- Smokers or users of nicotine replacement products
- Patients with a contraindication, e.g., allergy, for any of the medications or materials used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen, acetaminophen, Glycolon ® sutures, collagen sponge matrix)
- Patients with diabetes (glycemic level > 110mg/l and HbA1c > 6.5%)
- Drug or alcohol abuse history
- Pregnancy, lactation.
Show all 19Show fewer
- Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
- Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.
- Medications affecting periodontal status in the previous 6 months
- Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.
- Dental
- Patients with any history of palatal surgery
- Patients with inadequate donor site anatomy
- Poor oral hygiene
- Full-mouth plaque ≥ 20%
- Bleeding scores > 10%
- Untreated periodontitis
- Pocket depths > 3mm with BOP
- No active periodontal disease
Trial locations and contacts
1 site in 1 country.
Hailey Bivens, DDS contact
United States1 site, 1 recruiting
- Recruiting
Texas A&M College of Dentistry
Dallas, Texas, 75226
Ying S Wang, DDS, MS, 214-828-8282, yswang@tamu.edu
Hailey Bivens, DDS
About this study
Official title: Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial
The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are:
- Are there tissue thickness changes between the two groups (control group and augmentation group)?
- Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed.
Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.
Read the detailed description
The randomized controlled trial aims to investigate the potential effect of post-harvesting donor site augmentation on palatal volumetric changes following connective tissue graft harvesting.
The study investigation is a randomized controlled trial (RCT) that aims to have 20 participants in each group. The palatal thickness will be clinically assessed and a digital intraoral scan of the palate will be performed pre-operatively. A subepithelial connect tissue graft will then be harvested from the palate. Patients will then be randomly assigned to receive/not receive augmentation of the donor site, using a collagen sponge. Palatal thickness measurements and intraoral scans will be repeated at 2-, 4-, and 6-months postoperatively.
- Conditions
- Recession, Gingival
- Being tested
- Use of collagen matrix after subepithelial connective tissue graft harvest
- Keywords
- Subepithelial connective tissue graft, Collagen matrix, Collagen sponge, Soft tissue augmentation, Palatal volumetric change
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of collagen matrix after subepithelial connective tissue graft harvestDevice
Also called Helistat - collagen matrix group, Experimental
A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft. |
| Collagen Matrix | Experimental | Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft. Receives: Device: Use of collagen matrix after subepithelial connective tissue graft harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatal Thickness Change
Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
Measured: 2 months, 4 months, 6 months
Palatal Volume Change
Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.
Measured: 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomly assigned to be in the control group of the intervention group (Collagen matrix soft tissue augmentation).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hailey Bivens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hailey Bivens, Texas A&M University
- Investigators
- Ying S Wang, DDS, MS, Principal investigator, Texas A&M School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961566
- Sponsor's protocol ID
- IRB2023-0028
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05961566
- Acronym / sponsor ID
- IRB2023-0028
- Conditions
- Recession, Gingival
- Keywords
- Subepithelial connective tissue graft, Collagen matrix, Collagen sponge, Soft tissue augmentation, Palatal volumetric change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hailey BivensUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 27 Jul 2023 (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 randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are:
- Are there tissue thickness changes between the two groups (control group and augmentation group)?
- Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed.
Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.
Detailed description
The randomized controlled trial aims to investigate the potential effect of post-harvesting donor site augmentation on palatal volumetric changes following connective tissue graft harvesting.
The study investigation is a randomized controlled trial (RCT) that aims to have 20 participants in each group. The palatal thickness will be clinically assessed and a digital intraoral scan of the palate will be performed pre-operatively. A subepithelial connect tissue graft will then be harvested from the palate. Patients will then be randomly assigned to receive/not receive augmentation of the donor site, using a collagen sponge. Palatal thickness measurements and intraoral scans will be repeated at 2-, 4-, and 6-months postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to be in the control group of the intervention group (Collagen matrix soft tissue augmentation).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft. |
| Collagen Matrix | Experimental | Device: Use of collagen matrix after subepithelial connective tissue graft harvestIndividuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Demographic
- Medical History
- Dental history
- Other
Key exclusion criteria (19 listed)
- i. Medical History
- Dental
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 |
|---|---|---|
| Use of collagen matrix after subepithelial connective tissue graft harvestAlso: Helistat - collagen matrix group, ExperimentalA collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting. | Device | Collagen Matrix |
Primary outcome
Palatal Thickness Change
Time frame: 2 months, 4 months, 6 months
Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
Palatal Volume Change
Time frame: 2 months, 4 months, 6 months
Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Recession, Gingival
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
Gingival Graft, Recession, Gingival
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
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.
Hailey Bivens, DDS contact
Ying S Wang, DDS, MS principal investigator
Texas A&M School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of collagen matrix after subepithelial connective tissue graft harvest in people with Recession, Gingival, run by Hailey Bivens 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 17 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying S Wang, DDS, MS ((214) 828-8282, yswang@tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palatal Thickness Change (time frame: 2 months, 4 months, 6 months). The study lists 2 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 19 Jan 2024.