Clinical and Immunological Evaluation of HA in Treatment of Periodontitis

NCT06324474 | Not Yet Recruiting DMC

• 1 other identifier: HA treatment of periodontitis
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the immunological effectiveness of Hyaluronic acid as adjunction treatment to scaling and root planning and scaling and root planning alone. Comparison between clinical measurement before and after treatment. Evaluate the level of IGF-1 in treated site as immunological marker if periodontal regeneration.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (6)

• Changes in Plaque Index

  ranges from 0 to 3 score, where increasing in number indicates the worst case.

  From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

• Changes in Gingival Index

  Ranges from 0 to 3 stages, where increasing in number indicates the worst case.

  From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

• Changes in Papillary Bleeding Index.

  Ranges from 0 to 4 score, where increasing in number indicates the worst case

  From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

• Periodontal Probing Depth

  distance from the gingival margin to the base of the pocket

  From Baseline to 12th weeks post intervention '' changes from baseline to 12th week"

• Clinical attachment loss

  Distance from cemento-enamel junction to the base of pocket

  From baseline to 12th weeks post intervention "changes from baseline to 12th week

• Changes in IGF-1

  Through gingival cervical fluid serum collection

  From baseline to 12th weeks post intervention "changes from baseline to 12th week

Study Arms (2)

scaling and root planning with Hyaluronic acid application

EXPERIMENTAL

patients will receive Hyaluronic acid topical gel after scaling and root planning at first week and receive the gel after one week

Drug: Hyaluronic acid; Behavioral: scaling and root planning

scaling and root planning only

EXPERIMENTAL

patients will receive scaling and root planning only

Behavioral: scaling and root planning

Interventions

Hyaluronic acid DRUG

Gengigel syringe containing 1ml of 0.8% HA

Also known as: HA syringe

scaling and root planning with Hyaluronic acid application

scaling and root planning BEHAVIORAL

scaling and root planning using ultrasonic scaler

scaling and root planning only; scaling and root planning with Hyaluronic acid application

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• systemically healthy.
• at least 20 teeth and suffers from moderate \<7mm to severe. \>8mm.periodontitis with probing depth \>5m and in the contralateral side.
• ability to attend to the clinic in a regular manner.

You may not qualify if:

• allergy to HA.
• Chronic disease.
• orthodontic treatment.
• Qat chewer and smokers.
• antibiotic in previous 3 months.
• supplements and mouthwash.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Sana'a university

Sanaa, Yemen

Location

Related Publications (17)

• Polepalle T, Srinivas M, Swamy N, Aluru S, Chakrapani S, Chowdary BA. Local delivery of hyaluronan 0.8% as an adjunct to scaling and root planing in the treatment of chronic periodontitis: A clinical and microbiological study. J Indian Soc Periodontol. 2015 Jan-Feb;19(1):37-42. doi: 10.4103/0972-124X.145807.

  PMID: 25810591 BACKGROUND

• Al-Shammari NM, Shafshak SM, Ali MS. Effect of 0.8% Hyaluronic Acid in Conventional Treatment of Moderate to Severe Chronic Periodontitis. J Contemp Dent Pract. 2018 May 1;19(5):527-534.

  PMID: 29807962 BACKGROUND

• Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107.

  PMID: 26662482 BACKGROUND

• Alsakhawy SA, Baghdadi HH, El-Shenawy MA, Sabra SA, El-Hosseiny LS. Encapsulation of thymus vulgaris essential oil in caseinate/gelatin nanocomposite hydrogel: In vitro antibacterial activity and in vivo wound healing potential. Int J Pharm. 2022 Nov 25;628:122280. doi: 10.1016/j.ijpharm.2022.122280. Epub 2022 Oct 13.

  PMID: 36243326 BACKGROUND

• Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.

  PMID: 29926489 BACKGROUND

• Gontiya G, Galgali SR. Effect of hyaluronan on periodontitis: A clinical and histological study. J Indian Soc Periodontol. 2012 Apr;16(2):184-92. doi: 10.4103/0972-124X.99260.

  PMID: 23055583 BACKGROUND

• Sahayata VN, Bhavsar NV, Brahmbhatt NA. An evaluation of 0.2% hyaluronic acid gel (Gengigel (R)) in the treatment of gingivitis: a clinical & microbiological study. Oral Health Dent Manag. 2014 Sep;13(3):779-85.

  PMID: 25284557 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 BACKGROUND

• Dereka XE, Markopoulou CE, Vrotsos IA. Role of growth factors on periodontal repair. Growth Factors. 2006 Dec;24(4):260-7. doi: 10.1080/08977190601060990.

  PMID: 17381067 BACKGROUND

• Al-Khateeb R, Olszewska-Czyz I. Biological molecules in dental applications: hyaluronic acid as a companion biomaterial for diverse dental applications. Heliyon. 2020 Apr 6;6(4):e03722. doi: 10.1016/j.heliyon.2020.e03722. eCollection 2020 Apr.

  PMID: 32280803 BACKGROUND

• 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 BACKGROUND

• Van der Weijden GAF, Dekkers GJ, Slot DE. Success of non-surgical periodontal therapy in adult periodontitis patients: A retrospective analysis. Int J Dent Hyg. 2019 Nov;17(4):309-317. doi: 10.1111/idh.12399. Epub 2019 May 16.

  PMID: 30942938 BACKGROUND

• Pradeep AR, Kumari M, Rao NS, Naik SB. 1% alendronate gel as local drug delivery in the treatment of Class II furcation defects: a randomized controlled clinical trial. J Periodontol. 2013 Mar;84(3):307-15. doi: 10.1902/jop.2012.110729. Epub 2012 May 3.

  PMID: 22554293 BACKGROUND

• Ma S, Liu G, Jin L, Pang X, Wang Y, Wang Z, Yu Y, Yu J. IGF-1/IGF-1R/hsa-let-7c axis regulates the committed differentiation of stem cells from apical papilla. Sci Rep. 2016 Nov 11;6:36922. doi: 10.1038/srep36922.

  PMID: 27833148 BACKGROUND

• Sukumar S, Drizhal I. Hyaluronic acid and periodontitis. Acta Medica (Hradec Kralove). 2007;50(4):225-8.

  PMID: 18290544 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Hyaluronic Acid; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ghada Almuqayad, BDS

  Sana'a University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada Almuqayad, BDS

CONTACT

+967733855972; Ghadamqd@gmail.com

Wadhah Al-haj, Ass prof

CONTACT

+967773446446; Waddah.alhaj@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: March 22, 2024
• Study Start: April 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

YE (1)