Back to resultsEffect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
Primary Purpose
Pain, Postoperative, Gingival Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
amnion-chorion membrane
Sutures
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring grafting; tissue, amnion, chorion, gingival recession, wound healing
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:
- 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
Sites / Locations
- Harvard School of Dental MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sutures
Allograft and Sutures
Arm Description
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.
Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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?"
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.
• 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.
Full Information
NCT ID
NCT04957342
First Posted
June 17, 2021
Last Updated
August 17, 2022
Sponsor
Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT04957342
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Gingival Diseases
Keywords
grafting; tissue, amnion, chorion, gingival recession, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sutures
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Allograft and Sutures
Arm Type
Experimental
Arm Description
Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site.
Intervention Type
Biological
Intervention Name(s)
amnion-chorion membrane
Other Intervention Name(s)
BioXclude
Intervention Description
allograft to be placed on palate
Intervention Type
Procedure
Intervention Name(s)
Sutures
Intervention Description
Sutures (e.g. interrupted, crisscross compression) to be placed on palate
Primary Outcome Measure Information:
Title
Postoperative pain as evaluated by subjects using the Visual Analogue Scale
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Wound volumetric changes
Description
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.
Time Frame
60 days
Title
Patient satisfaction as evaluated by Visual Analogue Scale
Description
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.
Time Frame
60 days
Title
Pain management (medication usage)
Description
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?"
Time Frame
60 days
Title
Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
60 days
Title
• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a
Description
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.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Yu Chen, DDS, DMSc
Phone
857-576-0279
Email
chia-yu_chen@hsdm.harvard.edu
Facility Information:
Facility Name
Harvard School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Yu Chen, DDS, DMSc
Phone
857-576-0279
Email
chia-yu_chen@hsdm.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
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