Amnion-Chorion Membrane for Palate Wound Healing

Recruiting in San Antonio (>99 mi)

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: Unknown

74 Participants Needed

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.

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.

What 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. ^{1 2 3 4 5}

What 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. ^{1 6 7 8 9}

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. ^{2 5 8 9 10}

Research Team

Brian L Mealey, DDS, MS

Principal Investigator

University of Texas Health Science Center San Antonio

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.

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.

I am a woman who cannot become pregnant due to surgery or menopause.

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

Patients who disclose that they will not be able to cooperate with the follow-up schedule

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical Application of Hyperdry Amniotic Membrane in Cleft Palate Repair. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical application of a hyperdry amniotic membrane on surgical defects of the oral mucosa. [2012]

3. United States 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. [2018]

4. Korea (South) 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. [2022]

5. United States 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. [2020]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparative preclinical assessment of the use of dehydrated human amnion/chorion membrane to repair perforated sinus membranes. [2022]

7. England 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. [2021]

8. United States 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Amniotic membrane: new concepts for an old dressing. [2022]