Local Application of Hyaluronic Acid (HYADENT BG) With Free Soft Tissue Grafing Improves Treatment Outcomes.
1 other identifier
interventional
24
1 country
1
Brief Summary
A total of 24 healthy non-smoker patients requiring FGG recruited for the study. Subjects were equally and randomly assigned into two groups. Test group, local application of HYADENT BG on both donor and recipient sites. Control group, application of normal saline on both sites as placebo. The FGG dimensions were evaluated at 1, 3- and 6-month recall using digital photographs. Post-operative pain was evaluated for 14 days. Color matching and patient satisfaction were evaluated at 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2020
CompletedFirst Submitted
Initial submission to the registry
October 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2021
CompletedMarch 30, 2021
March 1, 2021
8 months
October 11, 2020
March 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
visual analogue scale (VAS) pain score
visual analogue scale (VAS) pain score in donor and receipt sites
7 days
surface area and color match
Clinical photographs were used to measure the surface area of the graft in all follow up periods, and to assess the color matching between the grafted area and the adjacent tissue at the end of the final follow-up visit on 6-month period
6 months
Study Arms (2)
Experimental
EXPERIMENTALlocal application of HYADENT BG on both donor and recipient sites
control
PLACEBO COMPARATORapplication of normal saline on both donor and recipient sites
Interventions
the operator topically applied the HYADENT BG on the borders of the graft after stabilization. on the donor site and injection of HYADENT BG in collagen sponge that was placed over the site, then figure X sutures to close the area using (4-0 polyglycolic acid/ reverse cutting/ 12 mm) resorbable sutures
Eligibility Criteria
You may qualify if:
- Healthy
- non-smoker,
- not taking any medication
You may not qualify if:
- Pregnant
- lactating women
- gingival pigmentation
- previous periodontal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jordan University of Science and Technology
Irbid, 21110, Jordan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2020
First Posted
March 30, 2021
Study Start
January 2, 2020
Primary Completion
September 1, 2020
Study Completion
September 5, 2020
Last Updated
March 30, 2021
Record last verified: 2021-03