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Completed

NCT Number: NCT04957342

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

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).

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard School of Dental Medicine

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

amnion-chorion membrane

Device

allograft to be placed on palate

Other names: BioXclude

Sutures

Procedure

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

Primary outcomes

  1. Postoperative pain as evaluated by subjects using the Visual Analogue Scale

    Time frame: 60 days

    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.

Secondary outcomes

  1. Wound volumetric changes

    Time frame: 60 days

    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.

  2. Patient satisfaction as evaluated by Visual Analogue Scale

    Time frame: 60 days

    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.

  3. Pain management (medication usage)

    Time frame: 60 days

    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?"

  4. Pain Catastrophizing Scale (PCS)

    Time frame: 60 days

    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.

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

    Time frame: 60 days

    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.

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2021
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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