Pain, PostoperativeNCT04957342
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
A study testing amnion-chorion membrane and Sutures in people with Pain, Postoperative and Gingival Diseases, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Gingival Diseases
- What is being tested?
- amnion-chorion membrane and Sutures
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02120
About this study
Official title: Wound Healing Following Palatal Graft Harvest Using Two Surgical Protocols - a Pilot Study
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
- Being tested
- amnion-chorion membrane, Sutures
- Keywords
- grafting; tissue, amnion, chorion, gingival recession, wound healing
- Medical subject headings
- Pain, Postoperative, Gingival Diseases, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amnion-chorion membraneDevice
Also called BioXclude
allograft to be placed on palate
SuturesProcedure or surgery
Sutures (e.g. interrupted, crisscross compression) to be placed on palate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sutures |
| Allograft and Sutures | Experimental | Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site. Receives: Device: amnion-chorion membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (5)
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.
Measured: 60 days
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.
Measured: 60 days
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?"
Measured: 60 days
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.
Measured: 60 days
• 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start15 May 2021
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Yu Chen, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957342
- Sponsor's protocol ID
- IRB20-1593
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Following Palatal Graft Harvest Using Two Surgical Protocols - a Pilot Study
- ClinicalTrials.gov ID
- NCT04957342
- Acronym / sponsor ID
- IRB20-1593
- Conditions
- Pain, Postoperative, Gingival Diseases
- Keywords
- grafting; tissue, amnion, chorion, gingival recession, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sutures | Active comparator | Procedure: SuturesPatients 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. |
| Allograft and Sutures | Experimental | Device: amnion-chorion membranePatients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Smoker
- Pregnancy [confirmed via patient self-identification]
- Systemic condition requiring antibiotic prophylaxis prior to any invasive procedure. The list of such conditions includes:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amnion-chorion membraneAlso: BioXcludeallograft to be placed on palate | Device | Allograft and Sutures |
| SuturesSutures (e.g. interrupted, crisscross compression) to be placed on palate | Procedure or surgery | Sutures |
Primary outcome
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.
5 secondary outcomes
Wound volumetric changes
Time frame: 60 days
Patient satisfaction as evaluated by Visual Analogue Scale
Time frame: 60 days
Pain management (medication usage)
Time frame: 60 days
Pain Catastrophizing Scale (PCS)
Time frame: 60 days
• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amnion-chorion membrane and Sutures in people with Pain, Postoperative and Gingival Diseases, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain as evaluated by subjects using the Visual Analogue Scale (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.