Effects of Polynucleotides and Hyaluronic Acid Based Subgingival Periodontal Pockets Re-instrumentation

Periodontal Pocket Clinical Trial

Official title:

Clinical and Biochemical Effects of the Adjunctive Use of a Polynucleotides and Hyaluronic Acid Based Gel in the Subgingival Re-instrumentation of Residual Periodontal Pockets: a Randomized, Split-mouth Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05210686
• Other study ID #: 4766 Prot n 947/17
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: May 2022
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled clinical trial (RCT) was to investigate the clinical and biochemical efficacy of a gel containing PDRN and HA used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.

Description:

The aim of the present study was to investigate the clinical and biochemical efficacy of a gel containing polynucleotides (PDRN) and hyaluronic acid (HA) used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.

50 patients were enrolled in a randomized, split-mouth clinical trial. For each patient, two teeth with similar residual pockets with probing depth (PD) ≥ 5 mm were selected to receive re-instrumentation with (test) or without (control) the adjunctive use of a PDRN and HA based gel. Differences in changes of PD, gingival recession (REC), clinical attachment level (CAL), modified sulcular bleeding index (mSBI), plaque index (PLI) from baseline to 6, 8, 24, 36 and 48 weeks were analyzed and the frequencies of sites with PD <4 mm at 48 weeks were compared. Furthermore, changes in the dosage of alpha-2-macroglobulin (α2M) and of matrix metalloproteinase-9 (MMP-9) from baseline to 6 weeks were evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 13, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• males and females with = 18 years

• stage 3 generalized periodontitis

• 3-6 months after step 1 and 2 of periodontal treatment, at least two non-adjacent teeth showing one residual pocket with probing depth (PD) =5, without mobility and without furcation involvement.

Exclusion Criteria:

• full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) >20%

• inadequate restorative therapy or malocclusion

• uncontrolled systemic disease

• immunosuppressive therapy or therapy with corticosteroid or with bisphosphonates

• inflammatory and autoimmune diseases of the oral cavity

• history of malignancy, radiation therapy or chemotherapy for malignancy in the last 5 years

• insulin-dependent diabetes;

• smoking (> 10 cigarettes per day)

• drug and alcohol abuse

• pregnant or lactating.

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

Other:
• subgingival re-instrumentation
subgingival re-instrumentation (control)

Locations

Country	Name	City	State
Italy	Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket depth	Clinical evaluations were performed by a blind calibrated examiner, different from the investigator who performed the treatment. At baseline (visit 1) and at 6 (visit 2), 8(visit 3), 24 (visit 4), 36 (visit 5) and 48 (visit 6) weeks using a periodontal probe	12 months