Clinical trial NCT04865952: Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part III
Official title: Effect of Hyaluronic Acid Application in Gene Expression and Cellular Behavior 24-hours After Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Wound Surgical
Oral Soft Tissue Conditions
Hyaluronic Acid
Keywords: early wound healing
gingival tissue
wound healing
hyaluronic acid
soft tissue injury
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split-mouth design
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study is to evaluate the effect of Hyaluronic acid application in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.

Detailed description: Although it has been demonstrated the role of HA in many different biological process related with tissue repair and regeneration, specific mechanisms involved in the early wound healing process in the oral soft tissues remains unclear.

A recent in vitro study evaluated the effects of two HA formulations on human oral fibroblasts involved in soft tissue wound healing/regeneration. The authors demonstrated that the investigated HA formulations maintained the viability of oral fibroblasts and increased their proliferative and migratory abilities. Moreover, enhanced expression of genes encoding type III collagen and transforming growth factor-β3, characteristic of scarless wound healing. Interestingly, TGFB1 remains unchanged. Moreover, compared to untreated control cells, either HA preparation upregulated the expression levels of COL3A1 in both HPFs and HGFs at 24 hour, whereas no effect on COL1A1 mRNA levels was detected The HAs upregulated the expression of genes encoding pro-proliferative, pro-migratory, and pro-inflammatory factors, with only a moderate effect on the latter in gingival fibroblasts. However, in vitro experiments have certain limitations. HA would undergo degradation to lower MW molecules following hyaluronidase activity during the post-operative period and will thus exert additional or even opposing effects on the wound repair process.28

To highlight, is the fact that in the latest years, the translational medicine focuses in research concerning scar-free wound healing tissues repair mechanisms and regarding this, it has been proposed that HA plays an important role in the fast and scarless fetal wound healing seeing during the first and second trimester.

Therefore, the aim of the present pilot study will be to evaluate the effect of hyaluronic acid application on gene expression and cellular behavior in the early wound healing process of gingival tissues. The second aim of the present work will be to evaluate the effect of HA in the wound healing clinical response.

Our hypothesis is that HA modifies the expression of genes related with the early wound healing response and the behavior of the main cells involved in this biological process: fibroblasts; stimulating and accelerating their wound healing potential.

Eligibility criteria: Inclusion Criteria:

* patients that required periodontal surgery;
* patients age between 30-60 years;
* patients with full mouth plaque score and full mouth bleeding score \< 15%;
* patients with a good general healthy status;
* patients without any medicaments or drug consumption that can affect the healing process;
* non-smoking patients.

Exclusion Criteria:

* patients in pregnancy;
* patients in lactation period;
* patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
* patients with systemic diseases.

Primary outcomes:
measure: Changes from baseline fold regulation wound healing related genes at 24 hours HA application
timeFrame: 24 hours after surgery (T24 hours)
measure: Clinical evaluation of early wound healing
timeFrame: 24 hours after surgery (T24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea Pilloni, MD,DDS,MS
role: STUDY_DIRECTOR
References:
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