Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach

NCT06897085 | Not Yet Recruiting

• 2 other identifiers: 7359Osteology Foundation
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Periodontitis; Gingival Recession, Localized; Aesthetic Perception; Aesthetic Outcomes

Keywords

minimally invasive; single flap approach

Outcome Measures

Primary Outcomes (1)

• Interproximal gingival recession (iREC)

  the primary outcome of the study will be iREC change

  6 months after surgical treatment of supraosseous defects

Secondary Outcomes (6)

• Prevalence of closed, non bleeding pockets

  6 months after surgical treatment

• Quality of early wound closure

  2-week follow-up

• Clinical Attachment Level (CAL) Gain

  6 months after surgical treatment

• Change in buccal gingival recession (bREC);

  6 months after surgical treatment

• Change in radiographic defect depth

  6 months after surgical treatment

Study Arms (2)

Single Flap Approach (SFA) plus gel containing polynucleotides and hyaluronic acid (PN-HA)

EXPERIMENTAL

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

Single Flap Approach (SFA) alone

SHAM COMPARATOR

Defects will receive a surgical intervention based on SFA alone (no PN-HA gel will be addedd)

Other: No intervention

Interventions

viscoelastic gel containing polynucleotides and hyaluronic acid DEVICE

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.

Single Flap Approach (SFA) plus gel containing polynucleotides and hyaluronic acid (PN-HA)

No intervention OTHER

Defects randomized to "control group" will be accessed with the SFA and no PN-HA gel will be applied.

Single Flap Approach (SFA) alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• failure to comply with study instructions/requirements.
• Site-specific
• presence of untreated endodontic lesions or inadequate endodontic treatment of teeth facing the SD;

Sponsors & Collaborators

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

Related Publications (6)

• Graziani F, Gennai S, Cei S, Ducci F, Discepoli N, Carmignani A, Tonetti M. Does enamel matrix derivative application provide additional clinical benefits in residual periodontal pockets associated with suprabony defects? A systematic review and meta-analysis of randomized clinical trials. J Clin Periodontol. 2014 Apr;41(4):377-86. doi: 10.1111/jcpe.12218. Epub 2014 Jan 22.

  PMID: 24329867 BACKGROUND

• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

  PMID: 32383274 BACKGROUND

• Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.

  PMID: 2066446 BACKGROUND

• Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.

  PMID: 12795787 BACKGROUND

• Simonelli A, Minenna L, Trombelli L, Farina R. Single flap approach with or without enamel matrix derivative in the treatment of severe supraosseous defects: a retrospective study. Clin Oral Investig. 2021 Nov;25(11):6385-6392. doi: 10.1007/s00784-021-03941-5. Epub 2021 Apr 14.

  PMID: 33855656 BACKGROUND

• Trombelli L, Farina R, Franceschetti G, Calura G. Single-flap approach with buccal access in periodontal reconstructive procedures. J Periodontol. 2009 Feb;80(2):353-60. doi: 10.1902/jop.2009.080420.

  PMID: 19186978 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Gingival Recession

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share