The Effect of Adjunctive Therapies in Regenerative Treatment of Stage III Grade C Periodontitis

NCT05447026 | Completed DMC

• 1 other identifier: 36290600/105
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Anti-infective procedures play a very important role in the success of regenerative surgical treatment of aggressive periodontitis, Grade C periodontitis, which shows the newly named molar-incisor pattern according to the 2017 World Workshop Classification of Periodontal Diseases. In the present study, it was aimed to analyze the effects of photodynamic, photobiomodulation, and ozone therapy applications on periodontal healing, both clinically and immunologically, in addition to the surgical regenerative treatment of aggressive periodontitis. Forty adult individuals diagnosed with aggressive periodontitis who applied to Gazi University Faculty of Dentistry Department of Periodontology for the treatment of periodontal disease were included in the study. In addition to the regenerative surgical treatment using cortico-cancellous particle allograft and a resorbable collagen membrane in randomly determined areas with multiple intraosseous defects, topical ozone, antimicrobial photodynamic, and light-emitting diode (LED) photobiomodulation treatments were applied. Periodontal clinical parameters \[plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depths (PPD), clinical attachment level (CAL), gingival recession (GR), and width of keratinized gingival (WKG)\] were examined and patient-centered postoperative evaluations, and early wound healing index (EHI) assessments were performed for 2 weeks after the operation. In addition, gingival crevicular fluid (GCF) samples from patients to determine the total amount and concentration of vascular endothelial growth factor (VEGF), interleukin -6 (IL-6), Runt-related transcription factor 2 (RunX2), NEL-like 1 (Nell-1), Osterix and samples were quantified by Quantitative Real-Time PCR. The repeated measures ANOVA model was used for the analysis of variables in which both group and time measurements were taken.

Conditions

Periodontitis; Lasers; Ozone; Wound Healing; Regeneration

Outcome Measures

Primary Outcomes (1)

• Changes in CAL values

  The changes in the mean CAL values between baseline and postoperative 6 months

  6 months after the surgery

Study Arms (4)

Control group

ACTIVE COMPARATOR

Regenerative surgical treatment of periodontal infrabony defects without any adjunctive therapies.

Device: Control group

antimicrobial photodynamic therapy (aPDT) group

ACTIVE COMPARATOR

Regenerative surgical treatment of periodontal infrabony defects in conjunction with irradiation by a diode laser and a photosensitizer

Device: Antimicrobial photodynamic therapy (aPDT) group

LED photobiomodulation group

ACTIVE COMPARATOR

Regenerative surgical treatment of periodontal infrabony defects in conjunction with irradiation by a LED device

Device: LED photobiomodulation group

Topical ozone group

ACTIVE COMPARATOR

Regenerative surgical treatment of periodontal infrabony defects in conjunction with topical ozone application

Device: Topical ozone group

Interventions

Control group DEVICE

Following local anesthesia, a full-thickness (muco-periosteal) access flap was elevated, granulation tissue was removed and direct instrumentation of the affected root surfaces was performed under the saline irrigation. Intrabony defects were filled with granules of allograft bone material and covered with a native porcine pericardial collagen membrane. The flaps were repositioned and sutured without any tension in order to achieve primary closure of the inter-dental area using a 5-0 mono-filament non-resorbable PTEF suturing material. On the 1st, 3rd, and 7th postoperative days, the sites in the control group received only saline irrigation for 1 min.

Control group

Antimicrobial photodynamic therapy (aPDT) group DEVICE

Following local anesthesia, a full-thickness (muco-periosteal) access flap was elevated, granulation tissue was removed and direct instrumentation of the affected root surfaces was performed under the saline irrigation. Intrabony defects were filled with granules of allograft bone material and covered with a native porcine pericardial collagen membrane. The flaps were repositioned and sutured without any tension in order to achieve primary closure of the inter-dental area using a 5-0 mono-filament non-resorbable PTEF suturing material. On the 1st, 3rd, and 7th postoperative days, aPDT group received additional application of a diode laser with a wavelength of 810 nm and a power rating of 200 mW (continuous mode). Indocyanine-green (ICG) as a photosensitizer at a concentration of 1 mg/ml was applied at the surgical site on both the buccal and the lingual sides of the flaps. Irradiation was performed in non-contact mode in a constant distance of 1 mm during 30 s per site

antimicrobial photodynamic therapy (aPDT) group

LED photobiomodulation group DEVICE

Following local anesthesia, a full-thickness (muco-periosteal) access flap was elevated, granulation tissue was removed and direct instrumentation of the affected root surfaces was performed under the saline irrigation. Intrabony defects were filled with granules of allograft bone material and covered with a native porcine pericardial collagen membrane. The flaps were repositioned and sutured without any tension in order to achieve primary closure of the inter-dental area using a 5-0 mono-filament non-resorbable PTEF suturing material. On the 1st, 3rd, and 7th postoperative days, irradiation was carried out with a LED device with a wavelength of 626 nm in the near-infrared region at a dose of 20 mw/cm2 for 20 min with a total energy of 222 J

LED photobiomodulation group

Topical ozone group DEVICE

Following local anesthesia, a full-thickness (muco-periosteal) access flap was elevated, granulation tissue was removed and direct instrumentation of the affected root surfaces was performed under the saline irrigation. Intrabony defects were filled with granules of allograft bone material and covered with a native porcine pericardial collagen membrane. The flaps were repositioned and sutured without any tension in order to achieve primary closure of the inter-dental area using a 5-0 mono-filament non-resorbable PTEF suturing material. On the 1st, 3rd, and 7th postoperative days, topical ozone group received ozone application with an ozone generator at 80% concentration using probe #3 for 30 s per site

Topical ozone group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• the presence of ≥ 20 teeth (excluding third molars);
• the presence of infrabony defects of ≥ 3 mm as detected in periapical radiographs;
• have not received any periodontal treatment and have not taken any of antibiotics within the last 6 months.

You may not qualify if:

• females that were pregnant or breastfeeding;
• systemic disease that could affect the risk or progression of periodontal disease (e.g., diabetes mellitus, bone metabolic disease, blood disorders, radiation or immuno-suppressive therapy);
• medications that significantly impact periodontal inflammation and bone metabolism (nonsteroidal anti-inflammatory drugs, bisphosphonates, selective serotonin reuptake inhibitors \[SSRIs\], proton pump inhibitors \[PPIs\], calcium channel blockers (CCBs), benzodiazepines, or corticosteroids);
• smokers or use of other tobacco products;
• teeth with class III furcation lesions or mobility degree \>1;
• periodontal treatment within the past 6 months prior to recruitment.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Dentistry

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (11)

• Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.

  PMID: 28805207 RESULT

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 RESULT

• 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 RESULT

• Diaz-Faes L, Fernandez-Somoano A, Magan-Fernandez A, Mesa F. Efficacy of regenerative therapy in aggressive periodontitis: a systematic review and meta-analysis of randomised controlled clinical trials. Clin Oral Investig. 2020 Apr;24(4):1369-1378. doi: 10.1007/s00784-020-03237-0. Epub 2020 Feb 14.

  PMID: 32060656 RESULT

• Collins JR, Ogando G, Gonzalez R, Figuero E, Marin MJ, Sanz M, Herrera D. Adjunctive efficacy of systemic metronidazole in the surgical treatment of periodontitis: a double-blind parallel randomized clinical trial. Clin Oral Investig. 2022 May;26(5):4195-4207. doi: 10.1007/s00784-022-04392-2. Epub 2022 Feb 5.

  PMID: 35122549 RESULT

• Andere NMRB, Castro Dos Santos NC, Araujo CF, Paz HES, Shaddox LM, Casarin RCV, Santamaria MP. Open flap debridement compared to repeated applications of photodynamic therapy in the treatment of residual pockets: A randomized clinical trial. J Periodontol. 2022 Nov;93(11):1671-1681. doi: 10.1002/JPER.22-0059. Epub 2022 Jun 2.

  PMID: 35536044 RESULT

• Giannelli M, Materassi F, Fossi T, Lorenzini L, Bani D. Treatment of severe periodontitis with a laser and light-emitting diode (LED) procedure adjunctive to scaling and root planing: a double-blind, randomized, single-center, split-mouth clinical trial investigating its efficacy and patient-reported outcomes at 1 year. Lasers Med Sci. 2018 Jul;33(5):991-1002. doi: 10.1007/s10103-018-2441-9. Epub 2018 Jan 18.

  PMID: 29349511 RESULT

• Zhao H, Hu J, Zhao L. The effect of low-level laser therapy as an adjunct to periodontal surgery in the management of postoperative pain and wound healing: a systematic review and meta-analysis. Lasers Med Sci. 2021 Feb;36(1):175-187. doi: 10.1007/s10103-020-03072-5. Epub 2020 Jul 1.

  PMID: 32613416 RESULT

• Heidari M, Fekrazad R, Sobouti F, Moharrami M, Azizi S, Nokhbatolfoghahaei H, Khatami M. Evaluating the effect of photobiomodulation with a 940-nm diode laser on post-operative pain in periodontal flap surgery. Lasers Med Sci. 2018 Nov;33(8):1639-1645. doi: 10.1007/s10103-018-2492-y. Epub 2018 Jul 6.

  PMID: 29978268 RESULT

• Katsikanis F, Strakas D, Vouros I. The application of antimicrobial photodynamic therapy (aPDT, 670 nm) and diode laser (940 nm) as adjunctive approach in the conventional cause-related treatment of chronic periodontal disease: a randomized controlled split-mouth clinical trial. Clin Oral Investig. 2020 May;24(5):1821-1827. doi: 10.1007/s00784-019-03045-1. Epub 2019 Aug 13.

  PMID: 31410672 RESULT

• Rapone B, Ferrara E, Santacroce L, Topi S, Gnoni A, Dipalma G, Mancini A, Di Domenico M, Tartaglia GM, Scarano A, Inchingolo F. The Gaseous Ozone Therapy as a Promising Antiseptic Adjuvant of Periodontal Treatment: A Randomized Controlled Clinical Trial. Int J Environ Res Public Health. 2022 Jan 16;19(2):985. doi: 10.3390/ijerph19020985.

  PMID: 35055807 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Deniz Ozbay, Prof Dr

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: An examiner, who was blinded for the patient group assignment, performed clinical measurements, and sample collections.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The present study is a parallel design randomized controlled clinical trial evaluating four different treatment approaches.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: January 1, 2018
• Primary Completion: February 10, 2022
• Study Completion: September 15, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)