Use of Hyaluronic Acid Gel in Intraosseous Defects

NCT06214728 | Completed

• 1 other identifier: UGUNDOGDU1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The aim of this randomised, parallel-arm, blinded, controlled clinical trial was to compare the clinical and radiographic efficacy of MINST with and without 0.8% HA gel application in the treatment of intraosseous defects. Research Hypothesis: The null hypothesis that there is no statistically significant difference in clinical and radiographic measurements between the use of HA gel in addition to MINST for the treatment of intraosseous defects and MINST treatment alone was tested.

Conditions

Periodontitis

Keywords

minimally invasive; nonsurgical periodontal debridements; periodontitis; alveolar bone loss; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Intraosseous defect depth (INFRA)

  It is the distance from the projection of the alveolar crest point on the tooth to the bottom of the defect (DD)

  Baseline - 6 months

Secondary Outcomes (2)

• Probing depth (PD)

  Baseline - 3months - 6 months

• Clinical attachment level (CAL)

  Baseline - 3months - 6 months

Other Outcomes (6)

• Gingival recession (GR)

  Baseline - 3months - 6 months

• Bleeding on probing (BoP)

  Baseline - 3months - 6 months

• Plaque (P)

  Baseline - 3months - 6 months

Study Arms (2)

MINST

PLACEBO COMPARATOR

Minimally invasive non-surgical treatment (MINST): Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage.

Procedure: Placebo gel application

MINST+HA

ACTIVE COMPARATOR

Minimally invasive non-surgical technique (MINST) with application of Hyaluronıc Acid gel: Using mini five curettes and ultrasonic devices with precise tips , the root surfaces were cleaned reaching to the base of the pocket, avoiding excessive root surface smoothing and gingival curettage. HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus.

Procedure: Hyaluronic acid gel application

Interventions

Hyaluronic acid gel application PROCEDURE

HA gel was applied to the periodontal pockets where the intraosseous defect was located using a sterile injector with a plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival application of HA was repeated 4 weeks after the first session.

MINST+HA

Placebo gel application PROCEDURE

The control group received placebo HA gel probe without rinsing. Placebo application was repeated 4 weeks after the first session.

MINST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of severe/progressed periodontitis (stage III/IV)
• Presence of an intraosseous defect with a probing depth ≥ 5 mm and defect depth ≥ 3 mm;
• Absence of furcation involvement,mobility and subgingival restoration in the vital tooth with intraosseous defect.

You may not qualify if:

• Systemic diseases
• Smokers
• Pregnant or lactating women
• Those who received periodontal treatment within the last 6 months

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy

Study Officials

• Sadiye Gunpinar, Asc. Prof.

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects having more than one intrabony defect that meets the inclusion criteria, only one intraosseous defect per patient was included based on a preliminary randomisation by a coin toss (UGE). Patients were then block randomised and the allocation sequence was computer-generated using www.randomizer.org. The patient groups were recorded by another investigator who did not perform the treatment application and clinical measurements (SG).

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: March 16, 2022
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

TU (1)