Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04957342 · ClinicalTrials.gov registry record · NA
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
A NA study of Pain, Postoperative and Gingival Diseases, sponsored by Harvard Medical School (HMS and HSDM).
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04957342: Completed NA study of Pain, Postoperative and Gingival Diseases, sponsored by Harvard Medical School (HMS and HSDM).
NCT04957342 is a NA study of Pain, Postoperative and Gingival Diseases that has completed, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 10 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04957342, a NA study of Pain, Postoperative and Gingival Diseases, has completed, sponsored by Harvard Medical School (HMS and HSDM).
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE amnion-chorion membrane
- PROCEDURE Sutures
Study Locations (1)
Massachusetts
- Harvard School of Dental Medicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-05-15 |
| Est. Completion | 2023-07-01 |
| Phase | NA |
What the finished NCT04957342 record still lists
NCT04957342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which amnion-chorion membrane is the first listed.
NCT04957342 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04957342 about?
NCT04957342 is a clinical study titled "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. Th...
What is the current status of trial NCT04957342?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-05-15. Estimated completion is 2023-07-01.
What conditions does trial NCT04957342 study?
This clinical trial studies the following conditions: Pain, Postoperative, Gingival Diseases.
What interventions are being tested in trial NCT04957342?
The interventions under investigation include: amnion-chorion membrane (DEVICE), Sutures (PROCEDURE).
Who is sponsoring clinical trial NCT04957342?
This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04957342 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04957342's enrollment target sits among peer trials
10 112th of 113 the lowest of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Randomized Control Trial, Cryoablation as an Adjunct to Surgical Stabilization of Rib Fractures
RECRUITING · NA
-
Dance Study for Post-surgical Pain in Breast Cancer Survivors
RECRUITING · NA
-
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
RECRUITING · NA
-
Anesthetic Optimization in Pediatric LeFort Surgeries
RECRUITING · NA
-
Latinx Children and Surgery
RECRUITING · NA
-
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI