Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part III

University of Roma La Sapienza

Status: Completed

Conditions: Wound Surgical; Oral Soft Tissue Conditions; Wound Heal; Hyaluronic Acid

Treatments: Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy; Other: HA application

Study type: Interventional

Funder types: Other

Identifiers

NCT04865952

5315 Prot 0640/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

HA application (treatment group - HA)

Experimental group

Description:

periodontal surgery + HA application + buccal attached gingival (G) biopsies 24 hr after surgical procedure

Treatment:

Other: HA application

Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy

NO HA application (non treatment group - NT)

Other group

Description:

periodontal surgery + buccal attached gingival (G) biopsies 24 hr after surgical procedure

Treatment:

Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy