Hyaluronic Acid for Residual Periodontal Pockets Adjunctive Treatment

NCT04702334 | Completed DMC

• 1 other identifier: MD-RO-BG-2015
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To evaluate the adjunctive effect of hyaluronic acid (HA) gel in the treatment of residual periodontal pockets over a 12-month period. Materials and Methods: Periodontal patients enrolled in maintenance and presenting at least one periodontal pocket 5-9 mm of depth in the anterior area were recruited from six university-based centers. Each patient was randomly assigned to control treatment with professional mechanical plaque removal (PMPR) and local placebo application or test treatment with the adjunctive use of HA to PMPR. Clinical parameters \[i.e. probing depth (PD), bleeding on probing (BoP), plaque score, recession (REC), and clinical attachment loss (CAL)\] and microbiological samples for the investigation of the total bacterial count (TBC) and presence of specific bacterial strains (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) were taken at baseline and every 3 months, until study termination. PD was determined as the primary outcome variable.

Conditions

Periodontitis

Keywords

hyaluronic acid; periodontitis; periodontal therapy; residual pockets

Outcome Measures

Primary Outcomes (1)

• PD (change is being assessed)

  probing depth (PD) measured with periodontal probe in mm

  at baseline and at 3, 6, 9, and 12 months after being treated

Secondary Outcomes (3)

• BoP(change is being assessed)

  at baseline and at 3, 6, 9, and 12 months after being treated

• Dental plaque(change is being assessed)

  at baseline and at 3, 6, 9, and 12 months after being treated

• REC(change is being assessed)

  at baseline and at 3, 6, 9, and 12 months after being treated

Other Outcomes (1)

• microbiological measurements(change is being assessed)

  at baseline and at 3, 6, 9, and 12 months after being treated

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel . This adjunctive treatment was performed at baseline and at the 3 months control.

Drug: Hyaluronic Acid

Lidocaine

PLACEBO COMPARATOR

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of anesthetic. This adjunctive treatment was performed at baseline and at the 3 months control.

Drug: Lidocain

Interventions

Hyaluronic Acid DRUG

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel for the test group . The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.

Also known as: Hyadent® BG, BioScience GmbH, Germany

Hyaluronic acid

Lidocain DRUG

After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of anesthetic for the control group. The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.

Also known as: Xylocaine® Dental

Lidocaine

Eligibility Criteria

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

You may qualify if:

• at least 18 years of age
• systemically healthy,
• smoking less than 10 cigarettes/day
• having been treated for periodontitis but with at least one single residual pocket of 5-9mm of depth located in the anterior area (incisors and canines)
• full-mouth bleeding score (FMBS)
• full-mouth plaque score (FMPS) less than 20%
• showing a good compliance to oral hygiene instructions

You may not qualify if:

• were pregnancy/lactation
• use of antibiotics in the last 3 months for a period of two weeks or more
• use of drugs causing gingival hyperplasia
• use of corticosteroids or anti-inflammatory drugs for a period of two weeks or more
• presence of diseases knowing to influence the wound healing/tissue response
• thyroid or pituitary gland malfunction or abnormal hormonal levels
• hyaluronic acid contraindications
• subjects under anticoagulant treatment
• use of systematic antibiotics for endocarditis prophylaxis
• radiation therapy in head and neck area
• use of bisphosphonate drugs prescribed for patients with osteoarthritis
• tooth mobility.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• University of Rijeka: collaborator
• University of Zagreb: collaborator
• Jagiellonian University: collaborator
• Medical University of Sofia: collaborator
• University of Bern: collaborator
• Plovdiv Medical University: collaborator

MeSH Terms

Conditions

Periodontitis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Blerina Zeza, DDS,MS,PhD

  University of Rome

  STUDY DIRECTOR

• Andrea Pilloni, DDS,Msc

  University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Clinical operators were kept blind until the moment of adjunctive treatment application allocated by the randomizer. Patients remained blinded during the entire follow-up. Microbiological evaluation and statistical interpretation of the results were made blinded on the treatment performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Periodontology

Model Details: All patients underwent a full mouth debridement completed within 48h in two consecutive visits. At reevaluation, a tooth entering the inclusion criteria was selected. After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel for the test group and local administration of anesthetic for the control group. The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket. Patients were advised not to drink or eat for 2 hours. This adjunctive treatment was performed at baseline and at the 3 months control. For both groups cleaning of supragingival tooth deposits and polishing was repeated at 3, 6, 9, and 12 months.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 8, 2021
• Study Start: January 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: once it is published
• Access Criteria: depending on the journal that could accept the paper