Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap
1 other identifier
interventional
42
1 country
1
Brief Summary
The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
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
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMarch 26, 2024
March 1, 2024
1 year
March 11, 2024
March 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of hyaluronic acid on recession reduction
The primary outcome is to examine the effectiveness of hyaluronic acid on the percentage of root coverage when treating multiple adjacent gingival recessions with the coronally advanced flap surgical technique
1 year
Secondary Outcomes (11)
To examine the effect of tissue thickness on recession coverage (KTt)
1 year
To examine keratinized gingiva width (KTw)
1 year
To examine changes in periodontal clinical parameters: PPD
1 year
To examine changes in periodontal clinical parameters: CAL
1 year
To examine changes in periodontal clinical parameters: REC
1 year
- +6 more secondary outcomes
Study Arms (2)
Coronally advanced flap with the hyaluronic acid
EXPERIMENTALThe experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF+HA).
Coronally advanced flap
OTHERThe control group refers to surgical intervention using a coronally advanced flap only to cover multiple gingival recessions without the addition of hyaluronic acid (CAF).
Interventions
The potential benefit of adding hyaluronic acid (HA) to the coronally advanced flap (CAF) operative technique to cover multiple adjacent recessions has not been sufficiently investigated. Improving aesthetics is one of the primary goals of root recession coverage periodontal surgery, and little is known about the same in multiple adjacent gingival recession coverage therapy. In patients with a sufficient amount (≥2 mm) of keratinized tissue, the coronally advanced flap (CAF) has been shown to be very effective in the treatment of multiple recessions, especially in terms of aesthetic results. The researchers concluded from a database search (Epistemonikos, Cochrane, Medline) that there is no evidence to support the use of HA + CAF to achieve greater root coverage in the treatment of multiple gingival recessions.
Eligibility Criteria
You may qualify if:
- age ≥ 18 years
- people without systemic diseases and chronic regular therapy
- non-smokers
- percentage of areas affected by plaque (FMPS) and percentage of bleeding sites on probing (FMBS) ≤25%
- the presence of a non-carious cervical lesion (NCCL) associated with recession
- gingival recessions on at least two adjacent teeth with a minimum depth of 2 mm and a clearly visible enamel-cement junction
- selection of patients capable of understanding and maintaining oral hygiene instructions with regular follow-up appointments
- selection of patients who fully understand the nature of the proposed surgical procedure and agree to informed consent
You may not qualify if:
- untreated periodontitis
- the presence of fixed prosthetic work (crown or bridge) on the examined adjacent teeth
- smokers
- pregnant and lactating women
- patients with uncontrolled type I and II diabetes
- patients with medical contraindications for surgical therapy
- medical history related to malignancies, radiotherapy, chemotherapy for the last 5 years
- taking chronic therapy that affects soft tissue healing such as: steroids, high doses of anti-inflammatory drugs, anticoagulants
- patients with active systemic infection
- allergies to hyaluronic acid
- allergies to local anesthesia
- alcohol or drug use
- participation in another clinical research in the past 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andelina Sekeljalead
Study Sites (1)
University of Zagreb - School of dental medicine
Zagreb, Hrvatska, 10 000, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization would first be generated using a computer-selected program, and then the protocol itself would be placed in opaque sealed envelopes and handed to the operator immediately before the procedure with a decision as to whether or not hyaluronic acid (HA) would be applied. In treated areas where HA will not be applied, the operative site will be treated only with saline. The patient as well as the researcher and the outcomes assesssor will not be informed which patient belongs to which group. Randomization and allocation of envelopes as well as allocation of patients to groups will be determined by a fourth party.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- doctor of dental medicine
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 26, 2024
Study Start
September 1, 2023
Primary Completion
September 1, 2024
Study Completion
June 1, 2025
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share