Clinical trial NCT04957342: Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
Official title: Wound Healing Following Palatal Graft Harvest Using Two Surgical Protocols - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Gingival Diseases
Keywords: grafting; tissue
amnion
chorion
gingival recession
wound healing
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Postoperative pain as evaluated by subjects using the Visual Analogue Scale
timeFrame: 60 days
Secondary outcomes:
measure: Wound volumetric changes
timeFrame: 60 days
measure: Patient satisfaction as evaluated by Visual Analogue Scale
timeFrame: 60 days
measure: Pain management (medication usage)
timeFrame: 60 days
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 60 days
measure: • Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a
timeFrame: 60 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
References: