NCT04957342

Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery

Wound Healing Following Palatal Graft Harvest Using Two Surgical Protocols - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Harvard Medical School (HMS and HSDM) · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

When harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. The primary disadvantage of this technique is the creation of a second surgical site. This sacrificial traumatic lesion on the palate is associated with significant post-operative morbidities, including patient discomfort, infection, inflammation, hemorrhage, and necrosis. A pilot, blinded Randomized Control Trial will be conducted with subjects who are treatment planned to receive free gingival graft palatal harvest surgery. The palatal wound donor site for treatment group 1 will not receive an allograft membrane; while the donor site for treatment group 2 will receive an amnion-chorion allograft membrane (BioXclude) secured with a suture. The severity of pain at the palatal wound site will be assessed using an at home survey (Visual Analog Scale, Pain Catastrophizing Scale, \& Patient-Reported Outcomes Measurement Information System Scale). The healing of the palatal donor site will be evaluated quantitatively and qualitatively (PVS impression, optical scan, endoscopy, and ultrasnonography).

Conditions

• Pain, Postoperative
• Gingival Diseases

Interventions

Type	Name	Description
DEVICE	amnion-chorion membrane	allograft to be placed on palate
PROCEDURE	Sutures	Sutures (e.g. interrupted, crisscross compression) to be placed on palate

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2021-07-12
• Last updated: 2025-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study