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Bone Graft
Bone Graft Materials for Wound Healing After Tooth Extraction
N/A
Recruiting
Led By Angela Palaiologou-Gallis, DDS
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 18-20 weeks
Awards & highlights
Study Summary
This trial is testing different combinations of bone graft materials to see which results in the best growth of new bone 18-20 weeks after the surgery.
Who is the study for?
This trial is for non-pregnant women, including those post-hysterectomy, tubal ligation, or menopause. Participants should be nonsmokers or light smokers (less than 10 cigarettes per day), have a tooth excluding molars needing extraction with enough bone height and space for an implant. Those with active infections other than periodontitis, heavy smokers, certain medical conditions affecting healing, or on specific medications are excluded.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of different graft materials in dental ridge preservation after tooth extraction. It will measure new bone formation using DFDBA fibers alone versus particulate form and combinations with xenograft material over approximately 18-20 weeks.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort at the site of surgery, swelling, bruising, infection risk at the graft site and delayed wound healing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tooth socket's bone wall is partially broken but not more than half.
Select...
I have enough jawbone height for dental implants without affecting my sinus or nerve canal.
Select...
I need one tooth (not a molar) removed as advised by a dentist.
Select...
I am scheduled to get a dental implant for my missing tooth.
Select...
I have enough jawbone height for dental implants without affecting my sinus or nerve canal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 18-20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 18-20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage vital bone formation
Secondary outcome measures
Change in buccal ridge height
Change in lingual ridge height
Change in ridge width
+2 moreTrial Design
4Treatment groups
Active Control
Group I: Group 3 Vallos-FActive Control1 Intervention
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Group II: Group 1 VallosActive Control1 Intervention
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Group III: Group 2 VallomixActive Control1 Intervention
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Group IV: Group 4 Vallomix-FActive Control1 Intervention
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,294 Total Patients Enrolled
Angela Palaiologou-Gallis, DDSPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Brian Mealey, DDS, MSPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
1 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My jawbone is not suitable for dental implants.If I become pregnant during the study, I will be withdrawn.My tooth socket's bone wall is partially broken but not more than half.I have enough jawbone height for dental implants without affecting my sinus or nerve canal.I am a woman who cannot become pregnant due to surgery or menopause.My tooth socket's bone damage does not extend beyond half its depth.I need one tooth (not a molar) removed as advised by a dentist.I am scheduled to get a dental implant for my missing tooth.I do not have any active infections, except possibly for gum disease.I have enough jawbone height for dental implants without affecting my sinus or nerve canal.My mouth can fit a dental implant.You smoke more than 10 cigarettes per day.I have a condition or take medication that may affect my body's healing.I have had heart infection after dental surgery.I am a woman who cannot become pregnant due to surgery or menopause.I do not smoke, or if I do, it's less than 10 cigarettes a day.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3 Vallos-F
- Group 2: Group 1 Vallos
- Group 3: Group 2 Vallomix
- Group 4: Group 4 Vallomix-F
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Wound Healing Patient Testimony for trial: Trial Name: NCT05400213 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible to join this clinical investigation?
"Affirmative. Clinicaltrials.gov lists this clinical trial as actively recruiting participants, having been posted on August 2nd 2022 and last updated the same day. 120 patients are required from a single medical facility."
Answered by AI
What is the cap for enrollment in this clinical trial?
"Affirmative, the information published on clinicaltrials.gov affirms that this medical trial is recruiting patients. Initially posted on August 2nd 2022 and last edited on the same date, 120 participants are required at a single research centre."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Nevada
How old are they?
18 - 65
What site did they apply to?
University of Texas Health Science Center at San Antonio (Dental School)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have needed a couple teeth extracted and am unable yet financially to get implants.
PatientReceived 2+ prior treatments
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