NCT05990049

Brief Summary

This study aims to evaluate the impact of locally applied hyaluronic acid on free gingival graft wound bed healing and palatal donor site wound healing. Forty subjects will be randomly divided in two separate groups. Test group will be treated with hyaluronic acid during the procedure and the control group without. Periodontal parameters and other clinical measurements will be taken on baseline, 7 days postoperative, 14 days postoperative, 1 month, 3 months and 6 months postoperative.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

July 3, 2023

Last Update Submit

August 13, 2023

Conditions

Hyaluronic AcidGingival Recession, LocalizedPain, Postoperative

Keywords

keratinized tissue widthshrinkagehyaluronic acidfree gingival graft

Outcome Measures

Primary Outcomes (6)

  • Keratinized tissue gain

    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

    baseline to 1 month postoperatively

  • Keratinized tissue gain

    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

    baseline to 3 months postoperatively

  • Keratinized tissue gain

    changes of the tissue in apico - coronal dimensions from gingival margin to mucogingival junction

    baseline to 6 months postoperatively

  • Shrinkage of the graft

    changes of the graft in apico - coronal and mesio-distal dimensions

    baseline to 1 month postoperatively

  • Shrinkage of the graft

    changes of the graft in apico - coronal and mesio-distal dimensions

    baseline to 3 months postoperatively

  • Shrinkage of the graft

    changes of the graft in apico - coronal and mesio-distal dimensions

    baseline to 6 months postoperatively

Secondary Outcomes (3)

  • Dimensional changes in gingival recessions

    baseline to 1 month postoperative

  • Dimensional changes in gingival recessions

    baseline to 3 months postoperative

  • Dimensional changes in gingival recessions

    baseline to 6 months postoperative

Study Arms (2)

Hyaluronic acid

ACTIVE COMPARATOR

During the surgery, the hyaluronic acid will be administered on donor site wound and on recipient site before suturing.

Drug: Hyadent BG

Control

NO INTERVENTION

After the harvesting of the graft from the donor site, the wound will be sutured using only saline to clean the wound. On the recipient site, before positioning the graft, only saline will be used.

Interventions

Hyadent BGDRUG

Hyadent BG is a cross-linked hyaluronic acid. 1,6% cross-linked hyaluronic acid (xHA), 0,2% native hyaluronic acid (HA)

Hyaluronic acid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no systemic disease
  • healthy
  • non-smokers
  • at least one tooth with keratinized tissue width less than 2 mm

You may not qualify if:

  • heavy smokers
  • younger than 18years old
  • using drugs
  • allergy on anesthesia
  • using drugs or alcohol
  • undergoing chemotherapy
  • undergoing radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dental Medicine University of Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Gingival RecessionPain, Postoperative

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Ana Badovinac, assoc prof

    School of Dental Medicine University of Zagreb

    STUDY DIRECTOR

Central Study Contacts

Ana Badovinac

CONTACT

+38598413512badovinac@sfzg.hr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 3, 2023

First Posted

August 14, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)