''Efficacy of Locally Delivered Hyaluronic Acid Gel as an Adjunctive to Non-Surgical Management of Periodontitis

NCT05834517 | Completed Phase 4

• 1 other identifier: FDASU-RECD125091
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts (Dahiya et al., 2013). Hyaluronic acid can be found in the skin, eyes and the periodontium. In addition, it appears in body fluids like serum, gingival crevicular fluid and saliva. Hyaluronic acid is created in the periodontium by HA synthase enzyme present in numerous cells like fibroblast and cementoblast (Fraser et al., 1997). There is evidence that hyaluronic acid is bacteriostatic, fungostatic, anti-inflammatory, osteoconduvtive and pro-angiogenic. These dissimilar properties illustrate the ability of hyaluronic acid to be an ideal material for wound healing (Carlson et al., 2004).

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• clinical score

  1-Plaque index (PI) 2. Sulcus bleeding index (BI) 3-Probing depth (PD) 4-Clinical attachment loss level (CAL)

  3 months

Secondary Outcomes (1)

• analyzing quantitative changes of pathogenic periodontal bacteria as a secondary objectives.

  1 month

Study Arms (2)

hyaluronic acid/ scaling

EXPERIMENTAL

topical application of hyaluronic acid after scaling by 1 day

Drug: Hyaluronic acid; Procedure: non surgical periodontal therapy

scaling

EXPERIMENTAL

scaling only

Procedure: non surgical periodontal therapy

Interventions

Hyaluronic acid DRUG

Hyaluronic Acid (HA) is an addition to the local chemotherapeutic agents. Hyaluronic acid was discovered by Meyer and Palmer. HA is widely found in the extracellular matrix and it plays an essential role in controlling cell behavior including random motility, metabolic reactions, chemotaxis, proliferation and invasion. HA is released by many cells including fibroblasts

Also known as: hyaluronan

hyaluronic acid/ scaling

non surgical periodontal therapy PROCEDURE

NSPT, with or without adjunctive therapies, is an effective treatment for periodontitis. It reduces PD and results in formation of some new attachment; however, it also has several limitations, and surgical therapy might be required to control inflammation and optimize outcomes. When used for non-surgical scaling and root planing, periodontal curettes can reach a mean PD of up to approximately 5.5 mm. The mean PD in which a plaque-free and calculus-free surface can be established is \<4 mm

hyaluronic acid/ scaling; scaling

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients have to be free from any systemic disease as proven by Burket's oral medicine health history questionnaire (Glik et al., 2008).
• Both genders aged 20-55.
• Periodontitis (Stage II or stage III) Patients; (3-6 mm CAL ,pocket depth ≤7 mm, mostly horizontal 15%-33% bone loss as assessed by preoperative radiographs with no tooth loss due to periodontitis) (Tonetti et al., 2017).

You may not qualify if:

• Pregnant lactating females
• Smoking
• Patients who can't be committed to oral hygiene instructions
• History of periodontal surgery or antimicrobial therapy for at least 4 months.

Sponsors & Collaborators

• Ehab Haider Hassan El-emam: lead

Study Sites (1)

Cairo

Cairo, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The eligible participants will be randomly allocated for one of the two groups; test and control group using computer generated random tables.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ehab haider hassan elemam

Model Details: topical application of hyaluronic acid in patients with periodontitis 1 day after scaling

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 28, 2023
• Study Start: May 2, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 10, 2022
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)