Flurbiprofen Versus Aloe Vera Gel in the Treatment of Chronic Periodontitis in Smoking Patients.

NCT06041178 | Completed Phase 4

• 1 other identifier: 2022-H-0100-D-R-0487
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate clinically the efficacy of flurbiprofen gel in comparison to Aloe Vera gel as adjunctive to SRP in the reduction of periodontal pockets in patients with chronic periodontitis in smoking patients. All patients will receive SRP prior to treatment.

• Group 1: one site will receive flurbiprofen while the contralateral site will receive a placebo
• Group 2: one site will receive aloe vera while the contralateral site will receive a placebo
• Group 3: one site will receive flurbiprofen while the contralateral site will receive aloe vera Researchers will compare the inter and intra-groups differences to check if there's a variation in the periodontal parameters measured.

Conditions

Periodontitis Chronic Generalized Severe

Outcome Measures

Primary Outcomes (2)

• clinical attachment level

  used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket

  6 months

• Probing Depth

  used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.

  6 months

Secondary Outcomes (3)

• Bleeding on Probing

  6 months

• Plaque index

  6 months

• Gingival index

  6 months

Study Arms (3)

scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site

EXPERIMENTAL

Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site

Drug: 2.5% flurbiprofen; Other: Placebo

scaling and root planing + 98% aloe vera on one site and placebo on contralateral site

EXPERIMENTAL

Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site

Drug: 98% aloe vera; Other: Placebo

scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site

EXPERIMENTAL

Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site

Drug: 2.5% flurbiprofen; Drug: 98% aloe vera

Interventions

2.5% flurbiprofen DRUG

Gel was made of 20% poloxamer and 10% ethanol as an Optimum formulation with sustained release up to 48 hours and a reasonable sol gel transition phase (adjunctive to SRP)

scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site; scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site

98% aloe vera DRUG

the Aloe vera gel employed possessed a concentration of 98% and was obtained from the reputable brand Avivir (Denmark). The remaining 2% comprised normal saline. The process of obtaining the 98% Aloe vera gel involved meticulous washing of mature Aloe Vera leaves under running water, followed by the removal of their outer skin. Subsequently, each leaf was divided into smaller pieces, from which the gel was allowed to seep out and carefully collected in a sterile container. The collected gel was then stored at 4°C until the time of its application in the study (adjunctive to SRP)

scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site; scaling and root planing + 98% aloe vera on one site and placebo on contralateral site

Placebo OTHER

saline

scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site; scaling and root planing + 98% aloe vera on one site and placebo on contralateral site

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Related Publications (39)

• Zhang S, Yu N, Arce RM. Periodontal inflammation: Integrating genes and dysbiosis. Periodontol 2000. 2020 Feb;82(1):129-142. doi: 10.1111/prd.12267.

  PMID: 31850627 BACKGROUND

• Sanchavanakit N, Saengtong W, Manokawinchoke J, Pavasant P. TNF-alpha stimulates MMP-3 production via PGE2 signalling through the NF-kB and p38 MAPK pathway in a murine cementoblast cell line. Arch Oral Biol. 2015 Jul;60(7):1066-74. doi: 10.1016/j.archoralbio.2015.04.001. Epub 2015 Apr 20.

  PMID: 25956994 BACKGROUND

• Offenbacher S, Farr DH, Goodson JM. Measurement of prostaglandin E in crevicular fluid. J Clin Periodontol. 1981 Aug;8(4):359-67. doi: 10.1111/j.1600-051x.1981.tb02045.x.

  PMID: 7033302 BACKGROUND

• Khan KM, Kothari P, Du B, Dannenberg AJ, Falcone DJ. Matrix metalloproteinase-dependent microsomal prostaglandin E synthase-1 expression in macrophages: role of TNF-alpha and the EP4 prostanoid receptor. J Immunol. 2012 Feb 15;188(4):1970-80. doi: 10.4049/jimmunol.1102383. Epub 2012 Jan 6.

  PMID: 22227567 BACKGROUND

• Eke PI, Wei L, Thornton-Evans GO, Borrell LN, Borgnakke WS, Dye B, Genco RJ. Risk Indicators for Periodontitis in US Adults: NHANES 2009 to 2012. J Periodontol. 2016 Oct;87(10):1174-85. doi: 10.1902/jop.2016.160013. Epub 2016 Jul 1.

  PMID: 27367420 BACKGROUND

• Kim J, Amar S. Periodontal disease and systemic conditions: a bidirectional relationship. Odontology. 2006 Sep;94(1):10-21. doi: 10.1007/s10266-006-0060-6.

  PMID: 16998613 BACKGROUND

• Ehizele A, Akhionbare O. Effect of non-surgical periodontal therapy on the concentration of volatile sulfur compound in mouth air of a group of nigerian young adults. Ann Med Health Sci Res. 2013 Jul;3(3):433-7. doi: 10.4103/2141-9248.117951.

  PMID: 24116328 BACKGROUND

• Choi YM, Lee JY, Choi J, Joo JY. Effect of root planing on the reduction of probing depth and the gain of clinical attachment depending on the mode of interproximal bone resorption. J Periodontal Implant Sci. 2015 Oct;45(5):184-9. doi: 10.5051/jpis.2015.45.5.184. Epub 2015 Nov 2.

  PMID: 26550527 BACKGROUND

• Morozumi T, Kubota T, Abe D, Shimizu T, Nohno K, Yoshie H. Microbiological effect of essential oils in combination with subgingival ultrasonic instrumentation and mouth rinsing in chronic periodontitis patients. Int J Dent. 2013;2013:146479. doi: 10.1155/2013/146479. Epub 2013 Sep 19.

  PMID: 24171000 BACKGROUND

• Goodson JM, Dewhirst FE, Brunetti A. Prostaglandin E2 levels and human periodontal disease. Prostaglandins. 1974 Apr 10;6(1):81-5. doi: 10.1016/s0090-6980(74)80043-2. No abstract available.

  PMID: 4595580 BACKGROUND

• Bacchi S, Palumbo P, Sponta A, Coppolino MF. Clinical pharmacology of non-steroidal anti-inflammatory drugs: a review. Antiinflamm Antiallergy Agents Med Chem. 2012;11(1):52-64. doi: 10.2174/187152312803476255.

  PMID: 22934743 BACKGROUND

• Ren J, Fok MR, Zhang Y, Han B, Lin Y. The role of non-steroidal anti-inflammatory drugs as adjuncts to periodontal treatment and in periodontal regeneration. J Transl Med. 2023 Feb 25;21(1):149. doi: 10.1186/s12967-023-03990-2.

  PMID: 36829232 BACKGROUND

• Marcum ZA, Hanlon JT. Recognizing the Risks of Chronic Nonsteroidal Anti-Inflammatory Drug Use in Older Adults. Ann Longterm Care. 2010;18(9):24-27.

  PMID: 21857795 BACKGROUND

• Sholapurkar A, Sharma D, Glass B, Miller C, Nimmo A, Jennings E. Professionally Delivered Local Antimicrobials in the Treatment of Patients with Periodontitis-A Narrative Review. Dent J (Basel). 2020 Dec 22;9(1):2. doi: 10.3390/dj9010002.

  PMID: 33375176 BACKGROUND

• Salvi GE, Lang NP. The effects of non-steroidal anti-inflammatory drugs (selective and non-selective) on the treatment of periodontal diseases. Curr Pharm Des. 2005;11(14):1757-69. doi: 10.2174/1381612053764878.

  PMID: 15892673 BACKGROUND

• Howell TH, Fiorellini J, Weber HP, Williams RC. Effect of the NSAID piroxicam, topically administered, on the development of gingivitis in beagle dogs. J Periodontal Res. 1991 May;26(3 Pt 1):180-3. doi: 10.1111/j.1600-0765.1991.tb01643.x.

  PMID: 1830620 BACKGROUND

• Deshpande NC, Bhat KM, Bhat GS, Deshpande AN. Randomized, controlled clinical study to evaluate efficacy of novel indigenously designed controlled release flurbiprofen gel system for management of periodontal diseases. Contemp Clin Dent. 2013 Jan;4(1):32-6. doi: 10.4103/0976-237X.111591.

  PMID: 23853449 BACKGROUND

• Saglam M, Kantarci A, Dundar N, Hakki SS. Clinical and biochemical effects of diode laser as an adjunct to nonsurgical treatment of chronic periodontitis: a randomized, controlled clinical trial. Lasers Med Sci. 2014 Jan;29(1):37-46. doi: 10.1007/s10103-012-1230-0. Epub 2012 Nov 16.

  PMID: 23161345 BACKGROUND

• Pradeep AR, Bajaj P, Agarwal E, Rao NS, Naik SB, Kalra N, Priyanka N. Local drug delivery of 0.5% azithromycin in the treatment of chronic periodontitis among smokers. Aust Dent J. 2013 Mar;58(1):34-40. doi: 10.1111/adj.12019. Epub 2013 Jan 30.

  PMID: 23441790 BACKGROUND

• Agarwal E, Pradeep AR, Bajaj P, Naik SB. Efficacy of local drug delivery of 0.5% clarithromycin gel as an adjunct to non-surgical periodontal therapy in the treatment of current smokers with chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2012 Sep;83(9):1155-63. doi: 10.1902/jop.2012.110600. Epub 2012 Jan 16.

  PMID: 22248223 BACKGROUND

• Eick S, Renatus A, Heinicke M, Pfister W, Stratul SI, Jentsch H. Hyaluronic Acid as an adjunct after scaling and root planing: a prospective randomized clinical trial. J Periodontol. 2013 Jul;84(7):941-9. doi: 10.1902/jop.2012.120269. Epub 2012 Oct 22.

  PMID: 23088524 BACKGROUND

• Prasad D, Kunnaiah R. Punica granatum: A review on its potential role in treating periodontal disease. J Indian Soc Periodontol. 2014 Jul;18(4):428-32. doi: 10.4103/0972-124X.138678.

  PMID: 25210254 BACKGROUND

• Krayer JW, Leite RS, Kirkwood KL. Non-surgical chemotherapeutic treatment strategies for the management of periodontal diseases. Dent Clin North Am. 2010 Jan;54(1):13-33. doi: 10.1016/j.cden.2009.08.010.

  PMID: 20103470 BACKGROUND

• Eid Abdelmagyd HA, Ram Shetty DS, Musa Musleh Al-Ahmari DM. Herbal medicine as adjunct in periodontal therapies- A review of clinical trials in past decade. J Oral Biol Craniofac Res. 2019 Jul-Sep;9(3):212-217. doi: 10.1016/j.jobcr.2019.05.001. Epub 2019 May 14.

  PMID: 31193290 BACKGROUND

• Taleghani F, Rezvani G, Birjandi M, Valizadeh M. Impact of green tea intake on clinical improvement in chronic periodontitis: A randomized clinical trial. J Stomatol Oral Maxillofac Surg. 2018 Nov;119(5):365-368. doi: 10.1016/j.jormas.2018.04.010. Epub 2018 Apr 30.

  PMID: 29723659 BACKGROUND

• Mekhemar M, Geib M, Kumar M, Radha, Hassan Y, Dorfer C. Salvadora persica: Nature's Gift for Periodontal Health. Antioxidants (Basel). 2021 Apr 30;10(5):712. doi: 10.3390/antiox10050712.

  PMID: 33946353 BACKGROUND

• Vogler BK, Ernst E. Aloe vera: a systematic review of its clinical effectiveness. Br J Gen Pract. 1999 Oct;49(447):823-8.

  PMID: 10885091 BACKGROUND

• Harlev E, Nevo E, Lansky EP, Ofir R, Bishayee A. Anticancer potential of aloes: antioxidant, antiproliferative, and immunostimulatory attributes. Planta Med. 2012 Jun;78(9):843-52. doi: 10.1055/s-0031-1298453. Epub 2012 Apr 19.

  PMID: 22516934 BACKGROUND

• Pareek S, Nagaraj A, Sharma P, Atri M, Walia S, Naidu S, Yousuf A. Disinfection of dental unit water line using aloe vera: in vitro study. Int J Dent. 2013;2013:618962. doi: 10.1155/2013/618962. Epub 2013 Sep 8.

  PMID: 24089615 BACKGROUND

• Im SA, Kim KH, Kim HS, Lee KH, Shin E, Do SG, Jo TH, Park YI, Lee CK. Processed Aloe vera gel ameliorates cyclophosphamide-induced immunotoxicity. Int J Mol Sci. 2014 Oct 24;15(11):19342-54. doi: 10.3390/ijms151119342.

  PMID: 25347273 BACKGROUND

• Athiban PP, Borthakur BJ, Ganesan S, Swathika B. Evaluation of antimicrobial efficacy of Aloe vera and its effectiveness in decontaminating gutta percha cones. J Conserv Dent. 2012 Jul;15(3):246-8. doi: 10.4103/0972-0707.97949.

  PMID: 22876011 BACKGROUND

• Doddanna SJ, Patel S, Sundarrao MA, Veerabhadrappa RS. Antimicrobial activity of plant extracts on Candida albicans: an in vitro study. Indian J Dent Res. 2013 Jul-Aug;24(4):401-5. doi: 10.4103/0970-9290.118358.

  PMID: 24047829 BACKGROUND

• Babaee N, Zabihi E, Mohseni S, Moghadamnia AA. Evaluation of the therapeutic effects of Aloe vera gel on minor recurrent aphthous stomatitis. Dent Res J (Isfahan). 2012 Jul;9(4):381-5.

  PMID: 23162576 BACKGROUND

• Pradeep AR, Agarwal E, Naik SB. Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial. J Periodontol. 2012 Jun;83(6):797-804. doi: 10.1902/jop.2011.110371. Epub 2011 Nov 16.

  PMID: 22087805 BACKGROUND

• Namiranian H, Serino G. The effect of a toothpaste containing aloe vera on established gingivitis. Swed Dent J. 2012;36(4):179-85.

  PMID: 23421308 BACKGROUND

• Chandrahas B, Jayakumar A, Naveen A, Butchibabu K, Reddy PK, Muralikrishna T. A randomized, double-blind clinical study to assess the antiplaque and antigingivitis efficacy of Aloe vera mouth rinse. J Indian Soc Periodontol. 2012 Oct;16(4):543-8. doi: 10.4103/0972-124X.106905.

  PMID: 23493442 BACKGROUND

• Ashouri Moghaddam A, Radafshar G, Jahandideh Y, Kakaei N. Clinical Evaluation of Effects of Local Application of Aloe vera Gel as an Adjunct to Scaling and Root Planning in Patients with Chronic Periodontitis. J Dent (Shiraz). 2017 Sep;18(3):165-172.

  PMID: 29034270 BACKGROUND

• Nayer Aboelsaad, et al. (2014) Clinical Efficacy of Local Delivered Minocycline in the Treatment of Chronic Periodontitis Smoker Patients. J Dent Oral Health 1: 1-5

  BACKGROUND

• Brad W. Neville DDS, ... Angela C. Chi DMD, in Color Atlas of Oral and Maxillofacial Diseases, 2019

  BACKGROUND

MeSH Terms

Interventions

Flurbiprofen

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nayer Aboelsaad, PhD

  Professor and Chairman of Periodontology department - BeirutArabU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: September 30, 2022
• Primary Completion: May 25, 2023
• Study Completion: July 19, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)