Amnion-Chorion Membrane for Palate Wound Healing
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: The University of Texas Health Science Center at San Antonio
Trial Summary
What is the purpose of this trial?This trial is testing if a special tissue bandage helps mouth surgery wounds heal better and reduces pain compared to a common gauze. The study focuses on patients who need healing in the roof of their mouth after surgery. The special tissue bandage has been used in various oral surgeries for tissue regeneration.
Is the amnion-chorion membrane a promising treatment for palate wound healing?
Yes, the amnion-chorion membrane is a promising treatment for palate wound healing. It contains growth factors and proteins that help speed up healing and tissue regeneration. It is also used in dentistry and other medical fields for its beneficial properties in wound care.
12568What safety data exists for amnion-chorion membrane treatment?
The safety data for amnion-chorion membrane treatment, including its use under various names like dehydrated human amnion/chorion membrane (dHACM), indicates it is generally safe. A case series involving five patients with chronic non-healing wounds treated with dHACM reported no adverse events, suggesting it is a safe and effective therapy. Additionally, a study comparing amnion-chorion membrane to collagen membrane in alveolar ridge preservation found no significant differences in healing or bone vitality, further supporting its safety. Overall, the available studies and literature reviews suggest that amnion-chorion membrane products are safe for clinical use in wound healing.
357810What data supports the idea that Amnion-Chorion Membrane for Palate Wound Healing is an effective treatment?
The available research shows that the Amnion-Chorion Membrane is effective for wound healing. One study focused on its use in cleft palate repair and found it to be safe and effective for closing wounds after surgery. Another study highlighted its success in treating nonhealing wounds, showing that it helps reduce inflammation and speeds up healing. Additionally, a pilot study compared healing with and without the membrane in oral surgery and found that the membrane improved healing outcomes. These findings suggest that the Amnion-Chorion Membrane is a beneficial treatment for palate wound healing.
146910Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for adults aged 18-89 needing gum surgery in the mouth area from back molar to back molar, whether they have teeth, implants, or none. Participants can be non-smokers or light smokers (less than 10 cigarettes a day), including women who are not pregnant and either post-menopausal, had tubal ligation/hysterectomy, or use contraception. They must also be able to follow up and own a smartphone.Participant Groups
The study compares two methods of healing after gum surgery: using an amnion-chorion membrane (ACM) versus ActCel Cellulose Gauze—a common bleeding control product. It aims to see if there's a difference in how the palate heals and how much pain patients feel with each treatment.
2Treatment groups
Active Control
Placebo Group
Group I: Use Amnio Chorion Membrane (ACM) with hemostatic agentActive Control2 Interventions
ACM or amnion-only membranes have been used in oral surgical procedures primarily because they contain a host of growth factors that play a role in normal wound healing.
Group II: Use of ActCel Cellulose Gauze (Commercial Hemostatic Agent)Placebo Group1 Intervention
Palatal wound dressing with hemostatic agent
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Texas Health Science Center at San Antonio (Dental School)San Antonio, TX
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
Clinical application of a hyperdry amniotic membrane on surgical defects of the oral mucosa. [2012]The aim of this study was to evaluate the usefulness of a hyperdry amniotic membrane (AM), a novel preservable human amnion, as a wound-dressing material for surgical defects of the oral mucosa.
Amniotic membrane: new concepts for an old dressing. [2022]The amniotic membrane is the innermost layer of fetal membranes that surrounds and protects the embryo. The amniotic epithelial cells are a rich source for biologically active factors known to promote cell proliferation and differentiation. Therefore, the amniotic membrane is considered to be an attractive wound dressing material. Despite a large number of publications reporting anti-inflammatory, bacteriostatic, reepithelializing, and scar-preventing properties of amniotic membrane, not all the molecular mechanisms underlying the beneficial actions of the amniotic membrane dressing have been fully elucidated. This review summarizes current knowledge on the properties of the amniotic membrane and its various clinical applications. It includes an overview of the main biologically active factors that may be responsible for the observed clinical effects of amnion dressings. This issue is briefly discussed in the context of the role of amnion processing and inter- and intradonor variations between amniotic membrane specimens. Finally, future directions for the use of amnion derivatives in wound care are indicated.
Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. [2021]A case series of five patients with a total of six chronic non-healing wounds (>30 day duration) were non-randomly selected to evaluate the performance, safety and handling properties of dehydrated human amnion/chorion membrane allograft, an amniotic membrane scaffolding product. The patients had lower extremity wounds that had previously failed standard of care within a university outpatient/inpatient wound healing programme. Five wounds treated with dehydrated amnion/chorion membrane allograft showed a mean 43% area reduction from baseline (51% median) at 3 weeks into treatment and completely healed with a 64-day median time to closure (SD ±27·6 days). One wound worsened at 3 weeks and was found to have a complete central vein obstruction that was treated with long-term mild compression but still eventually healed at 6 months. Removing this outlier, the four responding wounds had a 72% mean and 69% median change in area from baseline, at the 3 week point. All five patients received only one application of dehydrated human amnion/chorion membrane allograft, and there were no adverse events. The product was easy to use, administer and handle. In summary, dehydrated human amnion/chorion membrane allograft appears to be a safe, effective and easy to use therapy for chronic non-healing wounds. This study describes the details of these clinical cases and provides an overview of the current evidence on the use of amniotic tissue in clinical practice.
Use of Dehydrated Human Amnion/Chorion Membrane Allografts in More Than 100 Patients with Six Major Types of Refractory Nonhealing Wounds. [2018]Biochemical properties of the amniotic membrane help modulate inflammation and enhance soft-tissue healing. In controlled trials, the efficacy of dehydrated human amnion/chorion membrane (dHACM) allografts has been established. Our purpose is to describe our experience with using dHACM to treat nonhealing wounds of various etiologies.
Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. [2022]Recent advances in the preservation and processing of amnion/chorion tissue have dramatically increased the bioavailability of these wound healing factors as well as the shelf life of their related tissue products, allowing for a surge in clinical use. Many studies, including basic science, clinical trials, and randomized controlled trials, have emerged examining the biologic properties of amnion/chorion membrane products and their efficacy in wound healing.
Comparative Evaluation of the Efficacy of Human Chorion and Amnion With Coronally Advanced Flap for Recession Coverage: A Case Series. [2020]An amnion-chorion membrane is a placenta-derived tissue that has been introduced recently as a guided tissue regeneration membrane in dentistry. Numerous growth factors, proteins, and stem cell reserves in amnion could help in accelerated wound healing and regeneration, whereas chorion is a rich source of various collagen and non-collagen proteins. The present six-patient observational case series compares amnion and chorion allografts for recession coverage.
Comparative preclinical assessment of the use of dehydrated human amnion/chorion membrane to repair perforated sinus membranes. [2022]The aim of this study was to evaluate the use of dehydrated human amnion/chorion membrane (dHACM) to repair perforated sinus membranes in rabbits.
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes in Alveolar Ridge Preservation: A Clinical and Histological Study. [2021]Alveolar ridge preservation maintains ridge dimensions and bone quality for implant placement. The aim of this randomized controlled clinical study is to compare the use of a human amnion-chorion membrane to a collagen membrane in an exposed-barrier ridge preservation technique. Furthermore, this study will determine if intentional membrane exposure compromises ridge dimensions and bone vitality. Forty-three patients requiring extraction and delayed implant placement were randomly assigned into either the experimental or control group. Twenty-one participants received human amnion-chorion membrane (test) during ridge preservation while 22 participants received the collagen membrane (control). In both groups, demineralized freeze-dried bone allografts were used to graft the socket and primary closure was not achieved. The patients underwent implant placement after an average healing period of 19.5 weeks, and 2.7 × 8-mm core bone specimens were obtained for histomorphometric analyses. The clinical ridge dimensions were measured after extraction and at the time of delayed implant placement. No significant difference was observed in the mean vital bone formation between the experimental (51.72 ± 8.46%) and control (49.96 ± 8.31%; P > .05) groups. The bone height and width did not differ, as determined by clinical measurements (P > .05). Using either a human amnion-chorion membrane or type 1 bovine collagen as the open barrier did not change healing, compromise ridge dimensions, or affect bone vitality between the 2 groups.
Comparative evaluation of the efficacy of wound healing with and without dehydrated human amniotic/chorionic membrane in alveoloplasty: a pilot study. [2022]Wound healing is an integral part of any surgical procedure. Appropriate wound closure is critical to any successful surgical procedure, especially intraoral procedures. Various factors aid in wound healing, both pharmacological and non-pharmacological. Dehydrated human amniotic/chorionic membrane (dHACM) is an emerging bioinert material that contains anti-inflammatory properties, angiogenetic properties, osteogenic potential, and various growth factors. The purpose of this study was to evaluate the efficacy of wound healing properties of dHACM in bilateral alveoloplasty patients.
Clinical Application of Hyperdry Amniotic Membrane in Cleft Palate Repair. [2023]To examine the safety and efficacy of hyperdry amniotic membrane (HDAM) for wound closure after palatoplasty in cleft palate patients.