N/A
Completed N=72
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
Gingival Recession · Palate; Wound
Source: ClinicalTrials.gov NCT03895476 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Pain Assessment (0=No Pain to 10=Worst) — 4.2; 1.9; 2.2; 1 score on a scale
Summary
This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment (0=No Pain to 10=Worst) |
4.2; 1.9; 2.2; 1 | — |
| PRIMARY Bleeding Assessment |
1; 0.6; 0.9; 0.7 | — |
| SECONDARY Activity Tolerance |
2.4; 1.5; 1.8; 1.3 | — |
| SECONDARY Amount of Swelling |
2.2; 1.3; 1.4; 1.3 | — |
| SECONDARY The Need for Painkiller |
2.1; 2; 2.2; 1.5 | — |
Eligibility Criteria
Inclusion Criteria
- English speaking
- At least 18 years old- 70 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- Patients needing soft tissue graft with teeth that have miller class I or II recession (>=2mm) on the facial aspects
- Presence of periodontally healthy teeth at the recipient site.
- Ability of the participants to maintain good oral hygiene
- Patient not pregnant or breastfeeding
- Not taking medications known to cause gingival enlargement
Exclusion Criteria
- Non-English speaking
- Less than 18 years old, older than 70 years old
- Smokers/tobacco users
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Patients that have severe gingival recession (Miller class III and IV) or < 2 mm.
- Presence of periodontal disease at the recipient site.
- Poor oral hygiene
- Patient pregnant or breastfeeding
- Taking medications known to cause gingival enlargement
Data sourced from ClinicalTrials.gov (NCT03895476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.