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

NCT ID: NCT04957342

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2023-07-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sutures

Patients assigned to Sutures group will not have the allograft placed on the donor site. One current clinical standard of practice is to place sutures on donor site. Patients assigned to Sutures group will have sutures placed on donor site.

Group Type: ACTIVE_COMPARATOR

Sutures

Intervention Type: PROCEDURE

Sutures (e.g. interrupted, crisscross compression) to be placed on palate

Allograft and Sutures

Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site.

Group Type: EXPERIMENTAL

amnion-chorion membrane

Intervention Type: DEVICE

allograft to be placed on palate

Interventions

amnion-chorion membrane

allograft to be placed on palate

Intervention Type: DEVICE

Sutures

Sutures (e.g. interrupted, crisscross compression) to be placed on palate

Intervention Type: PROCEDURE

Other Intervention Names

BioXclude

Eligibility Criteria

Inclusion Criteria

• Patients age 18 and above
• No reported systemic disease that would compromise healing, such as Diabetes with A1c level >7.0%, endocrine disorders, hypertension above Stage II based on AHA 2017, osteoporosis, or immunodeficiency
• Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy.
• Clinical indication for periodontal mucogingival surgery utilizing palatal graft harvest e.g., shallow palatal vaults classified by Reiser et al. (1996) the average distance as 7 mm from the CEJ of maxillary teeth to the neurovascular bundle
• No history of previous palatal harvesting

Exclusion Criteria

• Smoker
• Pregnancy [confirmed via patient self-identification]
• Systemic condition requiring antibiotic prophylaxis prior to any invasive procedure. The list of such conditions includes:

1. Prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts

2. Prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords.

3. Previous infective endocarditis

4. Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device.

5. Cardiac transplant with valve regurgitation due to a structurally abnormal valve.

• Uncontrolled systemic disease e.g., Diabetes with A1c level > 7.0% endocrine disorders, hypertension above Stage II based on AHA 2017, osteoporosis, or immunodeficiency)
• Use of medications, such as Dilantin (aka Phenytoin), Cyclosporin, and Nifedipin, that would adversely affect periodontal tissues

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

Chia-Yu Chen

principla investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Harvard School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB20-1593

Identifier Type: -

Identifier Source: org_study_id