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amnion-chorion membrane for Gum Disease

N/A
Recruiting
Research Sponsored by Harvard Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

Study Summary

This trial will compare the healing of the palatal donor site when an allograft membrane is used versus when no allograft membrane is used.

Eligible Conditions
  • Gum Disease
  • Postoperative Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You need a specific type of dental surgery that involves taking tissue from the roof of your mouth. This is only needed if your mouth has a shallow area that is 7mm or less from the base of your teeth to a bundle of nerves and blood vessels.
Select...
You have not had surgery to remove tissue from the roof of your mouth before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative pain as evaluated by subjects using the Visual Analogue Scale
Secondary outcome measures
Pain Catastrophizing Scale (PCS)
Pain management (medication usage)
Patient satisfaction as evaluated by Visual Analogue Scale
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Allograft and SuturesExperimental Treatment1 Intervention
Patients assigned to Allograft and Sutures will have allograft placed and secured with sutures on the donor site.
Group II: SuturesActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Harvard Medical SchoolLead Sponsor
29 Previous Clinical Trials
40,839 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)Lead Sponsor
195 Previous Clinical Trials
1,316,019 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study participants are being accepted into this research?

"Correct. According to clinicaltrials.gov, this medical experiment is currently seeking participants and was originally posted on May 15th 2021. The last update of the study occurred on August 17 2022 and 10 individuals are expected to be recruited from a single site."

Answered by AI

Are there vacancies in this clinical research that volunteers can fill?

"Affirmative. Clinicaltrials.gov states that this study, posted on May 15th 2021, is currently accepting participants. Ten individuals are needed to be enrolled across 1 medical centre."

Answered by AI

Is it possible to join this experimental procedure?

"This clinical trial seeks approximately 10 participants who suffer from postoperative pain and range in age between 18 to 85 years. To be considered for the study, applicants must meet these criteria."

Answered by AI

Is this clinical exploration receptive to the participation of seniors?

"This trial adheres to a strict age restriction, permitting only individuals aged 18 - 85 years old to be included in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
Kendal Arielle Haddad 2021. "Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04957342.
~3 spots leftby Apr 2025
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