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NCT03567148
Evaluation of The Effectiveness of Different Methods for Healing a Palatal Donor Site After Harvesting a Free Gingival Graft
NA trial testing PRF in Wound Heal in 90 participants. Completed in 1 January 2018.
1 December 2017
Quick facts
| Lead sponsor | Gazi University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 January 2017 |
| Primary completion | 1 December 2017 |
| Estimated completion | 1 January 2018 |
Drugs / interventions tested
- PRF — full drug profile →
- Essix retainer
- Ozone therapy — full drug profile →
- LLLT
- Collagen fleece
Conditions studied
- Wound Heal — all drugs for Wound Heal →
- Graft Pain — all drugs for Graft Pain →
- Palate; Wound — all drugs for Palate; Wound →
Sponsor
Gazi University
Who can join
Adults 18 to 70, any sex, with Wound Heal or Graft Pain. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
VAS questionnaire regarding to postoperative pain
Time frame: 30th days postoperatively
The VAS was divided into 10 segments, and the patients were asked to rank their pain level using a scoring system ranging from 0 to 10
Sponsor's own description
Postoperative complications associated with free gingival graft (FGG) procedures are prolonged bleeding from the donor site, postoperative pain and delayed wound healing which increases the patients' morbidity. Hence, the aim of this study is to assess the effectiveness of different treatment modalities on palatal wound healing and patient's morbidity after FGG. Ninety patients requiring FGG were randomly will be assigned into six groups: group 1: Platelet rich fibrin (PRF) membrane, group 2: Essix retainer, group 3: topical ozone therapy, group 4: low-level laser therapy (LLLT), group 5: collagen fleece and group 6: untreated control group. Epithelization will be evaluated by means of bubble formation; sensitivity, edema, pain, changes in eating habits and burning sensation will be assessed by using visual analog scale (VAS) and also the presence of discomfort and bleeding will be evaluated in the postoperative first week and at 14 days, 1 and 3 months postoperatively.
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 NCT03567148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Currently open trials in the same condition.
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Other Gazi University 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 NCT03567148 (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 Gazi University
- Last refreshed: 12 June 2018
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/NCT03567148.
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