Clinical Comparison of Efficacy of Chlorhexidine Mouthrinses with and Without Hyaluronic Acid in Post-Implant Surgery Healing- A randomized controlled clinical trial

Maintenance of high level of oral hygiene plays a crucial role in success of any oral surgical procedure (1). Reduction of biofilm formation, prevention of infective complications on wound site and wound stability are very important for early wound healing (2). Reduction or elimination of oral biofilms is necessary to restore gingival tissues to a healthy state especially after a surgical procedure (3). However, mechanical means are often inadequate in ensuring plaque control and preventing infection at surgical sites (2,3). So, chemical agents can be used along with mechanical plaque control methods to ensure early wound healing (2).

Chlorhexidine is a widely used chemical antiplaque agent routinely prescribed to patients after common oral surgical procedures (1)(3)(4). It is a cationic bisbiguanide and has broad spectrum antimicrobial activity against gram positive bacteria, gram negative bacteria, yeast, viruses leading to chlorhexidine being a gold standard for oral biofilm prevention(3)(4). However recent studies have shown that a combination of chlorhexidine and hyaluronic acid can give better results when prescribed for post-surgical wound healing. (1),(2),(4),(5).

As it is widely known that for the completion of wound healing; hemostasis by platand osteotting factors, growth factors and cytokines followed by inflammatory response by the body leading to removal of bacteria, foreign bodies and damaged tissues accompanied with angiogenesis, fibroblast proliferation, collagen synthesis and maturation is absolutely necessary.(5) Hyaluronic acid has been known to promote neo angiogenesis, fibroblast synthesis, collagen maturation along with inhibition of destructive inflammation(2)(5).It is also known to have bacteriostatic, fungistatic, anti-inflammatory, anti-edematous and  osteo-inductive properties leading to overall improvement in wound healing response(2)

Dental implants have become increasingly popular due to their effectiveness in providing long term solutions for oral rehabilitation in partially or fully edentulous patients. It is important to note that a high level of oral hygiene is an important factor for the success of dental implant surgical technique (3). Hyaluronic acid (HA) is a versatile biomaterial that has many uses in dental implant surgery, it helps to prevent infections, promote healing and ensuring health of surrounding soft tissue structures.

Therefore, this study aims to compare the efficacy of two mouthwashes—chlorhexidine alone and chlorhexidine with hyaluronic acid on  wound healing after immediate and conventional dental implant surgery.

OBJECTIVES

1.     To evaluate wound healing outcomes following the use of chlorhexidine mouthwash post-implant surgery on days 3, 7, and 14 utilizing the wound healing index,

2.      To evaluate wound healing outcomes following the use of chlorhexidine combined with hyaluronic acid mouthwash post-implant surgery on days 3, 7, and 14 days using wound healing index.

3.     To evaluate the PROM(patient reported outcome measures ) among both the groups using Visual analogue scale and analgesic intake

4.     To conduct both intergroup and intragroup comparisons of the outcomes.

Group1(control group): commercially available chlorhexidine mouthwash. The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days.

Group2(experimental group): commercially available mouthwash containing chlorhexidine with hyaluronic acid. (0.2 percent CHX + 0.2 percent HA). The mouth rinse protocol consists of a 10 ml-rinse for 60 s twice-a-day (every 12 h) for 14 days.

 Mouth rinsing will be clearly explained after surgery and patients will be advised to begin it the next morning of the surgical intervention. Each study participant will be requested rinse with 10ml allotted mouthwash 60 secs twice daily for 14 days.  Patients will also be instructed in oral hygiene maneuvers like the brushing techniques. Enrolled participants will be examined at 3, 7, and 14 days after surgery to assess the degree of wound healing and patient’s acceptance (PROM). Clinical pictures of the surgical area will also be taken using mobile phone camera of at least 12 megapixel resolution.

Re-assessment evaluation

At T3, T7, and T14, the WHI score will be clinically evaluated at treated area.

At T3, the first follow-up examination will be performed. WHI and PROM will be evaluated.

At T7 (second follow-up examination), WHI and PROM will be evaluated.

At T14 (third follow-up examination), the last registration of WHI and PROM will be evaluated.