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

NCT04957342 | Completed DMC FDA Device

• 1 other identifier: IRB20-1593
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

grafting; tissue; amnion; chorion; gingival recession; wound healing

Outcome Measures

Primary Outcomes (1)

• Postoperative pain as evaluated by subjects using the Visual Analogue Scale

  The primary purpose of this study is to determine patient-reported outcome measures (i.e., pain) during the immediate post-operative period (i.e., 60 days). The Visual Analogue Scale survey will be completed by the patients during clinical visits and remotely. The scale ranges from a score of 0 to 10, with a higher score corresponding to more severe pain experienced post-op.

  60 days

Secondary Outcomes (5)

• Wound volumetric changes

  60 days

• Patient satisfaction as evaluated by Visual Analogue Scale

  60 days

• Pain management (medication usage)

  60 days

• Pain Catastrophizing Scale (PCS)

  60 days

• • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a

  60 days

Study Arms (2)

Sutures

ACTIVE COMPARATOR

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.

Procedure: Sutures

Allograft and Sutures

EXPERIMENTAL

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

Device: amnion-chorion membrane

Interventions

amnion-chorion membrane DEVICE

allograft to be placed on palate

Also known as: BioXclude

Allograft and Sutures

Sutures PROCEDURE

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

Sutures

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smoker
• Pregnancy \[confirmed via patient self-identification\]
• Systemic condition requiring antibiotic prophylaxis prior to any invasive procedure. The list of such conditions includes:
• Prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts
• Prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords.
• Previous infective endocarditis
• 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.
• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Gingival Diseases; Gingival Recession

Interventions

Sutures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Twenty subjects (20) requiring mucogingival surgery and palatal graft harvest will be recruited into study. The randomization will be achieved by preparing 20 envelopes, 10 envelopes containing materials for the palatal wound treatment #1 (empty packaging materials) and 10 envelopes containing materials for palatal wound treatment #2 (BioXclude membrane \& suture). A blinded study team member will randomly hand the designated cohort allocation materials to the periodontology resident preforming the palatal wound dressing treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principla investigator

Model Details: The primary purpose of this study is to determine patient-reported outcome measures (i.e., pain and satisfaction) during the immediate post-operative period. Participants will be randomly allocated into two study groups (see Study Design for the randomization process). The palatal wound treatment group #1 will not receive an allograft dressing. The palatal wound treatment group #2 will receive a thin bandage (BioXclude, Snoasis Medical) underneath the suture. At the time of the procedure and post-op days 14 and 60, a research team member will administer the survey, take an impression, photograph the surgical site, and collect extra measurements, probing depth (PD), recession (REC), \& clinical attachment level (CAL), of the participants' mouth. The subject will also be asked to remotely complete a brief survey twice per day for eight days after surgery.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 12, 2021
• Study Start: May 15, 2021
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (1)