Amnion-Chorion Membrane for Palate Wound Healing

Overseen By Angela Palaiologou-Gallis, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Mental incompetence, Pregnancy, Smoking >10/day, others

Compensation: Varies

Number of Visits: 5

Duration: 1 day

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to aid wound healing in the mouth after surgery. Researchers aim to determine if a special membrane, amnion-chorion, which contains growth factors that aid healing, is as effective as a common gauze called ActCel. They compare the treatments' effects on healing and the level of pain patients experience afterward. Individuals needing oral surgery between their molars and who have access to a smartphone might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from innovative treatments.

Do 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the amnion-chorion membrane (ACM) is generally safe for use in oral surgeries. One study found it effective in repairing cleft palates, as it helped close wounds well after surgery. Another study confirmed its safety when used on mouth wounds.

The amnion-chorion membrane aids in healing wounds, reducing swelling, and supporting tissue growth. These benefits make it a good choice for surgeries in the mouth and jaw area. So far, no major safety issues have been reported with using ACM in these situations.

The current study phase is "Not Applicable," indicating no new data about side effects in this trial yet. However, existing research strongly indicates its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Amnion-Chorion Membrane (ACM) for palate wound healing because it harnesses the power of natural growth factors found in amnion and chorion tissues. Unlike traditional treatments like standard gauze or collagen dressings, ACM offers a biological approach that actively promotes healing by delivering these growth factors directly to the wound site. This innovative method has the potential to speed up recovery and improve overall healing outcomes, making it a promising alternative to existing options.

What evidence suggests that the Amnion-Chorion Membrane is effective for palate wound healing?

This trial will compare the use of the amnion-chorion membrane (ACM) with ActCel Cellulose Gauze for palate wound healing. Studies have shown that ACM aids wound healing by containing substances that promote cell growth and new blood vessel formation. In one study, ACM performed as well as traditional collagen dressings for healing areas after gum surgery. Another study found ACM safe and effective for closing wounds after cleft palate repairs. These findings suggest ACM could be a promising option for improving healing and reducing pain in palate surgeries. ^{2 6 7 8 9}

Who Is on the Research Team?

Brian L Mealey, DDS, MS

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a nonsmoker, former smoker, or smoke less than 10 cigarettes a day.

I need a dental procedure in my upper or lower jaw, from back to front, regardless of having teeth or implants.

Must have access to Smartphone

Exclusion Criteria

Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)

Pregnant women or women intending to become pregnant during the study period

I smoke more than 10 cigarettes a day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo periodontal plastic surgery with either Amnio-Chorion Membrane or ActCel Cellulose Gauze applied to the palatal donor site

1 day

1 visit (in-person)

Follow-up

Participants are monitored for wound healing and pain perception post-surgery

4 weeks

Weekly visits (in-person) for 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ActCel Cellulose Gauze
• Amnion-Chorion Membrane

Trial Overview 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.

How Is the Trial Designed?

Group I: Use Amnio Chorion Membrane (ACM) with hemostatic agent Active Control 2 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 Group 1 Intervention

Palatal wound dressing with hemostatic agent

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

Amnion/chorion membranes have been shown to significantly enhance wound healing in various conditions, including diabetic foot ulcers and difficult-to-heal fistulas, when used alongside standard treatments.

Clinical trials indicate that patients receiving amniotic membrane products experience higher rates of wound healing compared to those receiving standard care, highlighting their efficacy in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. Kogan, S., Sood, A., Granick, MS.[2022]

In a study involving 10 patients undergoing bilateral alveoloplasty, the use of dehydrated human amniotic/chorionic membrane (dHACM) significantly improved wound healing compared to standard suturing without dHACM.

Statistical analysis showed a significant difference in healing outcomes (P<0.05), indicating that dHACM may enhance recovery in surgical procedures by leveraging its anti-inflammatory and growth factor properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of the efficacy of wound healing with and without dehydrated human amniotic/chorionic membrane in alveoloplasty: a pilot study. Gajul, M., Bhate, K., Awate, S., et al.[2022]

The amniotic membrane, derived from fetal membranes, contains amniotic epithelial cells that release biologically active factors promoting cell growth and healing, making it a promising material for wound dressings.

Despite its known benefits such as anti-inflammatory and scar-preventing properties, the specific molecular mechanisms behind these effects are not fully understood, highlighting the need for further research into amniotic membrane applications in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane: new concepts for an old dressing. Litwiniuk, M., Grzela, T.[2022]

In a study of 117 patients treated with dehydrated human amnion/chorion membrane (dHACM) allografts over 2 years, 91.1% achieved complete healing of their nonhealing wounds, demonstrating the efficacy of this treatment.

dHACM was effective for various types of wounds, including diabetic foot ulcers and venous leg ulcers, with an average of 5.1 weekly applications needed for healing, indicating its potential as a versatile option in advanced wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Dehydrated Human Amnion/Chorion Membrane Allografts in More Than 100 Patients with Six Major Types of Refractory Nonhealing Wounds. Garoufalis, M., Nagesh, D., Sanchez, PJ., et al.[2018]

In a study involving 43 patients, the use of human amnion-chorion membranes for alveolar ridge preservation showed no significant difference in bone vitality or dimensions compared to collagen membranes, indicating both are effective options.

After an average healing period of 19.5 weeks, neither membrane type compromised ridge dimensions or bone vitality, suggesting that intentional exposure of the membranes does not negatively impact the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes in Alveolar Ridge Preservation: A Clinical and Histological Study. Faraj, SA., Kutkut, A., Taylor, RC., et al.[2021]

Hyperdry amniotic membrane (HDAM) was found to be a safe and effective method for wound closure after palatoplasty in 16 cleft palate patients, with no reported infections or complications during a follow-up period of over 31 months.

All patients were able to feed normally within 5 days post-surgery, and there were no instances of postoperative bleeding, wound dehiscence, or severe scarring, indicating that HDAM promotes good healing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of Hyperdry Amniotic Membrane in Cleft Palate Repair. Fujiwara, K., Tsuno, H., Okabe, M., et al.[2023]

In a study involving 14 rabbits, the use of dehydrated human amnion/chorion membrane (dHACM) for repairing perforated sinus membranes showed promising results, with significant new bone formation compared to the negative control group that did not receive repair.

The effectiveness of dHACM in promoting bone regeneration was comparable to that of a resorbable collagen membrane, indicating that dHACM is a viable option for sinus membrane repair during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative preclinical assessment of the use of dehydrated human amnion/chorion membrane to repair perforated sinus membranes. Chang, YY., Kim, SH., Goh, MS., et al.[2022]

In a case series of five patients with chronic non-healing wounds, the use of dehydrated human amnion/chorion membrane allograft resulted in a significant mean area reduction of 43% at 3 weeks, with complete healing achieved in a median time of 64 days.

The treatment was safe, with no adverse events reported, and was easy to administer, indicating that dehydrated amnion/chorion membrane allograft could be an effective option for patients whose wounds have not responded to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. Mrugala, A., Sui, A., Plummer, M., et al.[2021]

In a study involving six patients with 12 recession defects, both amnion and chorion membranes significantly improved clinical parameters related to gum health, including root coverage and keratinized gingiva width, at 3 and 6 months post-surgery.

Nine out of 12 recession defects achieved 100% root coverage, indicating that both types of membranes are effective options for periodontal plastic surgeries, promoting healing and improving gingival biotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of the Efficacy of Human Chorion and Amnion With Coronally Advanced Flap for Recession Coverage: A Case Series. Pundir, AJ., Agrawal, V., Pundir, S., et al.[2020]

The hyperdry amniotic membrane (AM) was evaluated in 10 patients as a wound-dressing material for oral mucosal defects after cancer surgery, showing ease of handling and good adherence to tissues.

The study indicated that the hyperdry AM is safe and effective, with no significant adverse effects during healing and a high average patient satisfaction score of 11.2 out of 14, suggesting it could be a viable option for oral wound repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of a hyperdry amniotic membrane on surgical defects of the oral mucosa. Arai, N., Tsuno, H., Okabe, M., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9221211/

Investigating the Effects of Dehydrated Human Amnion ... These findings suggest that GFs contained in dHACM promote proliferation and migration of PDLCs and angiogenesis, which lead to enhanced periodontal healing.

2. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/abs/10.1002/jper.11370

Clinical and histological outcomes of allogenic amnion ... This study looked at how well 2 different treatments help wounds heal after a free gingival graft procedure, which requires taking donor tissue ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40627760/

Clinical and histological outcomes of allogenic amnion ... In conclusion, ACM was found to be as effective as the collagen dressing in promoting healing at the donor site, meaning both treatments can be ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/73/NCT03713073/Prot_SAP_000.pdf

Clinical and Histological Outcomes of Allogenic Amnion ... This study aims to compare an allogenic amnion chorion membrane (BioXclude®,. SNOASIS MEDICAL) to a collagen dressing (Collagen Patch®, Zimmer) ...

5. withpower.com withpower.com/trial/phase-wounds-and-injuries-7-2023-3578d

Amnion-Chorion Membrane for Palate 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8222622/

Surgical Application of Human Amniotic Membrane and ... Herein, we investigate the potential use of hAM and amnion-chorion membrane (ACM) in oral surgery. Based on our analysis of the literature, it appears that ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03713073

Clinical and Histological Outcomes of Allogenic Amnion ... The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11051762/

Introduction to Amniotic Membranes in Maxillofacial ... Amniotic membranes offer a versatile and effective option in maxillofacial surgery, promoting wound healing, reducing inflammation, and providing a scaffold ...

9. mdpi.com mdpi.com/1422-0067/26/17/8470

The Human Amniotic Membrane: A Rediscovered Tool to ... Wound healing in oral surgery is influenced by systemic conditions (aging, diabetes) and habits (smoking, alcoholism), which can hinder the natural ...