Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach (SFA-SD)

March 26, 2025 updated by: Anna Simonelli, Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in the Treatment of Periodontal Supraosseous Defects with the Single Flap Approach: a Randomized Controlled Trial

Treatment of supraosseous defects (SD) may be challenging due to their limited regenerative potential. When located in aesthetic areas, treatment may result in a gingival recession increase with consequent patients' concerns in terms of aesthetic or tooth sensibility. In the present study, a minimally-invasive surgical procedure (namely, the Single Flap Approach, SFA) will be combined with the application of a viscoelastic gel containing polynucleotides and hyaluronic acid that was reported to positively modulate periodontal wound healing. The outcomes, evaluated 6 months after treatment, will be compared to those obtained with SFA alone. The evaluated outcomes will be either clinical (evaluation of clinical parameters such as gingival recession, residual probing depth, clinical attachment gain) or related to patient's perception (such as evaluation of the aesthetic or tooth sensibility).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

SDs have been indicated as the most challenging lesions when dealing with periodontal regenerative procedures. In fact, their non-containing morphology does not contribute wound stability, and the wound maturation phase does not benefit from the cellular support coming from residual lateral bony walls, as in intraosseous defects. Also, the absence of residual bony walls does not allow a proper support of the surgical flaps, thus reducing the space needed for regeneration. Because of this unfavorable morphology, treatment of SDs generally results in worse clinical outcomes compared to intraosseous defects. Nevertheless, noteworthy clinical results have been reported when SDs associated to moderate or deep PD were treated with open flap debridement alone. In a systematic review Graziani et al. (2014), showed mean PD reductions of 1.41 mm in sites of moderate pre-surgical pocket depth (i.e., mean PD of 5.19 mm) that reached mean residual pockets of 3.83 mm over 6 months after treatment. More recently, a high prevalence of closed pockets (i.e., 79.3% of sites with residual PD ≤ 3mm) have been reported 12 months after treatment of deep (i.e., mean presurgical value of 6.3 ±0.6 mm) sites with access flap based on papilla preservation techniques (i.e., Modified/Simplified Papilla Preservation Technique).

In 2021, the Single Flap Approach (SFA), a surgical technique originally introduced in the treatment of intraosseous defects, have been also proposed for SDs. The basic principle underlying the SFA is the elevation of a single flap (i.e., on the buccal or oral aspect only, depending on the main extension of the defect) to access the defect, leaving the interproximal supracrestal soft tissue intact. Data stemming from a retrospective analysis showed that the SFA with or without EMD was similarly effective in the treatment deep bleeding pockets associated to a horizontal pattern of bone destruction. In the study arm receiving SFA as a stand-alone protocol, significant mean CAL gains (2.1± 0.9 mm) and PD reductions (3.1± 1.0 mm) were observed 12 months after therapy. These results appear similar or even superior when compared to those reported by other studies where SDs were accessed with Double Flap Approach (based on Papilla Preservation Techniques) alone. Interestingly, this observation has been confirmed by a recent study where clinical and radiographic outcomes observed after surgical access of SDs performed by either a SFA or a DFA were compared. At 6 months, treatment with SFA resulted in greater prevalence of sites reaching CAL gain ≥ 1mm (80% vs 11%) and PD≤ 3mm (40% vs 10%) compared to DFA, thus suggesting that SFA principles may lead to improved clinical outcomes compared to DFA even in the treatment of SDs.

Although the evidence from previous studies support the SFA as a promising treatment for SDs, some clinical aspects currently need further investigation. In the study by Simonelli et al. (2021), a tendency to suboptimal wound closure was evident, with 30% of defects undergoing SFA alone showing Early Healing Index (EHI) scores of 4 or 5 at 2 weeks after surgery. Based on data coming from a previous study demonstrating a trend towards better clinical outcomes (greater CAL gain, less buccal REC increase) in defects with optimal wound closure compared to incomplete wound closure, we may hypothesize that this aspect could have negatively influenced the observed clinical results. In fact, 1-year CAL gain (2.1 mm) was limited if compared to pre-surgery CAL (7.5 mm), and a mean gingival recession (REC) increase of 1 mm was observed.

Recently, a viscoelastic gel containing polynucleotides and hyaluronic acid (PN-HA) was shown to positively influence the viability and proliferation of gingival fibroblasts, thus representing a plausible candidate as periodontal wound modulator. These in vitro results had been partially confirmed by a clinical study where the use of a PN-HA gel showed a higher tendency to pocket closure after subgingival re-instrumentation of PD≥ 5 mm. To date, no clinical data on the effectiveness of PN-HA gel after surgical treatment of SDs is available.

Primary aim The primary aim of the study will be to evaluate the superiority of SFA + PN-HA gel over SFA for the change in interproximal gingival recession (iREC) observed 6 months after surgery of SDs in esthetic areas.

Secondary aims The secondary aims of the study will be to comparatively evaluate SFA + PN-HA gel and SFA for the (i) 6-month prevalence of closed, non-bleeding pockets (i.e., PD≤ 4mm); (ii) quality of early wound closure; (iii) 6-month CAL gain; (iv) 6-month change in buccal gingival recession (bREC); (v) 6-month change in radiographic defect depth; (vi) duration of the surgical procedure; (vii) PROMs, including adverse events, postoperative pain intensity/duration, and patient satisfaction.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA Patient-specific

  • age≥ 18 years;
  • diagnosis of Stage III or IV periodontitis22;
  • good physical status (ASA1 and ASA2 according to Physical Status Classification System);
  • systemic and local conditions compatible with periodontal surgical procedures;
  • patient willing and fully capable to comply with the study protocol.

Site-specific

  • defect located in an incisor, canine or premolar region which becomes exposed during spontaneous smiling;
  • defect with an intrabony component (as assessed on periapical radiograph and confirmed intra-surgically) ≤ 2 mm;
  • defect with a radiographic CEJ-BC≥ 4 mm; d) residual (following step I-II of treatment) PD≥6 mm at both interproximal aspects facing the SD.

EXCLUSION CRITERIA Patient-specific

  • poorly controlled diabetes (HbA1C ≥ 7%);
  • history of radiation therapy in the head and neck area;
  • history of chemotherapy;
  • systemic disease or conditions with a documented effect on bone metabolism and/or periodontal status/healing;
  • past (within 6 months prior to enrollment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or periodontal status/healing;
  • physical or mental handicap that can interfere with adherence to the study procedures and adequate hygienic compliance;
  • documented allergy to dental materials involved in the experimental protocol;
  • pregnancy or lactation;
  • history of drug or alcohol abuse.

Moreover, participants will be immediately excluded from the study:

  • upon request to withdraw from further participation;
  • development of acute dental/periodontal or oral conditions requiring treatment;
  • development of conditions conflicting with the exclusion criteria listed above
  • failure to comply with study instructions/requirements.

Site-specific

  • presence of untreated endodontic lesions or inadequate endodontic treatment of teeth facing the SD;
  • presence of orthodontic appliances;
  • local conditions preventing proper plaque control at experimental sites;
  • grade III mobility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Flap Approach (SFA) plus gel containing polynucleotides and hyaluronic acid (PN-HA)
Defects treated in this study arm will receive a surgical intervention based on the SFA and will receive the application of PN-HA gel at the completion of defect debridement.
Device: viscoelastic gel containing polynucleotides and hyaluronic acid
Defects randomized to "test treatment" will receive a viscoelastic gel containing polynucleotides and hyaluronic acid (PN-HA gel) immediately at the completion of intra-surgical instrumentation. PN-HA gel will be also applied on the surgical wound at the completion of the suturing phase.
Sham Comparator: Single Flap Approach (SFA) alone
Defects will receive a surgical intervention based on SFA alone (no PN-HA gel will be addedd)
Other: No intervention
Defects randomized to "control group" will be accessed with the SFA and no PN-HA gel will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interproximal gingival recession (iREC)
Time Frame: 6 months after surgical treatment of supraosseous defects
the primary outcome of the study will be iREC change
6 months after surgical treatment of supraosseous defects

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of closed, non bleeding pockets
Time Frame: 6 months after surgical treatment
closed pocket (i.e., residual 6-month probing depth (PD)≤ 4mm)
6 months after surgical treatment
Quality of early wound closure
Time Frame: 2-week follow-up

The quality of early wound closure will be evaluated using the "early healing index" (EHI), as proposed by Wachtel et al. in 2003.

EHI is based on the following scale: (EHI=1) complete flap closure, no fibrin line in the interproximal area; (EHI=2) complete flap closure, fine fibrin line in the interproximal area; (EHI=3) complete flap closure, fibrin clot in the interproximal area; (EHI=4) incomplete flap closure, partial necrosis of the interproximal tissue; and (EHI=5) incomplete flap closure, complete necrosis of the interproximal tissue.
2-week follow-up
Clinical Attachment Level (CAL) Gain
Time Frame: 6 months after surgical treatment
6-month CAL gain will be calculated by subtracting the 6-month CAL value from the baseline CAL
6 months after surgical treatment
Change in buccal gingival recession (bREC);
Time Frame: 6 months after surgical treatment
bREC change will be calculated by subtracting the 6-month bREC value from the baseline bREC value
6 months after surgical treatment
Change in radiographic defect depth
Time Frame: 6 months after surgical treatment
change in radiographic defect depth will be calculated by subtracting the 6-month radiographic defect depth value from the baseline radiographic defect depth value
6 months after surgical treatment
PROMs
Time Frame: post-operative days 1, 2, 7 and 14

PROMs will include adverse events, postoperative pain intensity/duration, and patient satisfaction.

Both "postoperative course" and "patient satisfaction" will be assessed through a self-administered questionnaire and/or a VAS (1-100) ranging from "0 - no pain/no satisfaction" to "100 - intolerable pain/full satisfaction".
post-operative days 1, 2, 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7359
  • Osteology Foundation (Other Grant/Funding Number: Project number: 23-031)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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