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NCT04957342
Effect of Using Placental Membranes on Healing and Post-op Pain After Gum Surgery
NA trial testing amnion-chorion membrane in Pain, Postoperative in 10 participants. Completed in 1 July 2023.
1 May 2023
Quick facts
| Lead sponsor | Harvard Medical School (HMS and HSDM) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 15 May 2021 |
| Primary completion | 1 May 2023 |
| Estimated completion | 1 July 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- amnion-chorion membrane
- Sutures
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Gingival Diseases — all drugs for Gingival Diseases →
Sponsor
Harvard Medical School (HMS and HSDM)
Who can join
Adults 18 to 85, any sex, with Pain, Postoperative or Gingival Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04957342
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Harvard Medical School (HMS and HSDM) trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04957342 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM)
- Last refreshed: 14 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04957342.
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