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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04957342
• Other study ID #: IRB20-1593
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2022
• Source: Harvard Medical School (HMS and HSDM)
• Contact: Chia-Yu Chen, DDS, DMSc
• Phone: 857-576-0279
• Email: chia-yu_chen[@]hsdm.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Pain, Postoperative

Intervention

Biological:
• amnion-chorion membrane
allograft to be placed on palate

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

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound volumetric changes	At the time of the procedure and post-op days 14 and 60, a research team member will administer the survey, take an impression, endoscopic image, ultrasonography, photograph the surgical site, and collect extra measurements, probing depth (PD), recession (REC), & clinical attachment level (CAL), of the participants' mouth. These records will combined to report volumetric changes of donor site in mm^3.	60 days
Secondary	Patient satisfaction as evaluated by Visual Analogue Scale	The secondary purpose of this study is to determine patient-reported outcome measures (i.e., satisfaction) 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 0 to 10, with a higher score corresponding to a higher degree of satisfaction.	60 days
Secondary	Pain management (medication usage)	The secondary purpose of this study is to determine patient-reported outcome measures (i.e., medication usage) during the immediate post-operative period (i.e., 60 days). The survey will be completed during clinical visits and remotely. The survey will ask the following: "Did you take any medications for pain management of the palatal wound site? What medications & how much?"	60 days
Secondary	Pain Catastrophizing Scale (PCS)	In order to address the subject nature of pain, subjects will be administered the Pain Catastrophizing Scale in the survey (completed during clinical visits and remotely). Each answer choice will be assigned a number, with a higher number reflecting a higher degree of pain experience ("Not at all" is 0; "All the time" is 4). A total score will be calculated as the sum of all answer choices. Total score ranges from 0 to 52, with a higher score corresponding to higher frequency of feelings and thoughts related to pain.	60 days
Secondary	• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a	In order to address the subject nature of pain, subjects will be administered the PROMIS pain interference form in the survey (completed during clinical visits and remotely). Each answer choice will be assigned a number, with a higher number reflecting a higher degree of pain interference ("Not at all" is 0; "Very much" is 4). A total score will be calculated as the sum of all answer choices. Total score ranges from 0 to 32, with a higher score corresponding to a higher degree of pain interference.	60 days