Effectiveness of Thyme Honey in Management of Xerostomia in ESRD

NCT05247008 | Completed DMC

• 1 other identifier: 972
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The oral health of older people has warranted considerable research attention in the last two to three decades. One of the most oral conditions that have been related to the elderly patients was xerostomia. An elderly population that has a high rate of comorbid disease is likely to continue for the foreseeable future. Among these pathologies, End stage renal disease (ESRD) stands out as a common serious age-related disease. ESRD is a chronic irreversible renal failure. It is known also as chronic kidney disease (CKD) Stage 6 or CKD 6. Xerostomia is relatively common in patients having ESRD with prevalence ranging from 28% to 67%. Multiple pharmacological and non-pharmacological measures that have been tested in previous studies in order to improve xerostomia in patients with ESRD which were based on the stimulation of the salivary gland flow. A new alternative for the control of xerostomia is the use of thyme honey, which is a propolis gel product with strong antioxidant, antibacterial, antifungal and immunomodulation effect. It is believed that the presence of honey in the oral cavity has a sialagogue effect, stimulating the salivary glands to produce more saliva, due to the high sugar concentration in honey. The purpose of the study is to determine whether the use of thyme honey as mouth rinse will help in the treatment of xerostomia in geriatric patients with end-stage renal disease (symptom management).

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• Changes in subjective dry mouth score

  Changes in subjective dry mouth score \[ Time Frame: baseline, 2 weeks and 4 weeks after intervention\] The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of thyme honey mouth rinse (for at least 5 days per week)

  one month

Secondary Outcomes (4)

• Increase in unstimulated Salivary Flow Rate (ml/min)

  one month

• Increase in salivary Nitric oxide levels (mmol/L) using clorimetric determination method

  one month

• Changes in objective dry mouth score

  one month

• Changes in salivary Potential of Hydrogen ion (pH)

  one month

Study Arms (1)

Thyme honey interventional arm in geriatric patients having end-stage renal disease.

OTHER

Thyme honey used as mouth rinse in treatment of xerostomia in geriatric patients with end-stage renal disease.

Other: Thyme honey

Interventions

Thyme honey OTHER

* Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.

Thyme honey interventional arm in geriatric patients having end-stage renal disease.

Eligibility Criteria

• Age: 61 Years+
• Gender Eligibility Details: Both genders with end-stage renal disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders, of minimum 61 years.
• All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
• Patients on hemodialysis ≥ 3 months (Bots et al., 2005).
• All patients must have complaint of xerostomia.
• Objective dry mouth score from ( 2-5).
• Subjective dry mouth score from (1-4).
• Patients must be able to make reliable decision or communications.

You may not qualify if:

• \- Smoking, Alcohol. Healthy patients.
• Patient with history of any serious illness as malignancy, who undergo kidney transplant.
• Patients with any autoimmune disease.
• Patients with diabetes mellitus (Charalambous et al., 2017).
• Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11668, Egypt

Location

Related Publications (22)

• Afsaneh Abadi P, Koopaie M, Montazeri R. Comparison of salivary nitric oxide and oral health in diabetic patients with and without xerostomia. Diabetes Metab Syndr. 2020 Jan-Feb;14(1):11-15. doi: 10.1016/j.dsx.2019.11.014. Epub 2019 Nov 25.

  PMID: 31809967 BACKGROUND

• Alam F, Islam MA, Gan SH, Khalil MI. Honey: a potential therapeutic agent for managing diabetic wounds. Evid Based Complement Alternat Med. 2014;2014:169130. doi: 10.1155/2014/169130. Epub 2014 Oct 15.

  PMID: 25386217 BACKGROUND

• Anil S, Vellappally S, Hashem M, Preethanath RS, Patil S, Samaranayake LP. Xerostomia in geriatric patients: a burgeoning global concern. J Investig Clin Dent. 2016 Feb;7(1):5-12. doi: 10.1111/jicd.12120. Epub 2014 Sep 1.

  PMID: 25175324 BACKGROUND

• Bardow A, Nyvad B, Nauntofte B. Relationships between medication intake, complaints of dry mouth, salivary flow rate and composition, and the rate of tooth demineralization in situ. Arch Oral Biol. 2001 May;46(5):413-23. doi: 10.1016/s0003-9969(01)00003-6.

  PMID: 11286806 BACKGROUND

• Belcher J. Dressings and healing with honey. Br J Nurs. 2014 Mar 27-Apr 9;23(6):S22. doi: 10.12968/bjon.2014.23.Sup6.S22.

  PMID: 24690746 BACKGROUND

• Biswal BM, Zakaria A, Ahmad NM. Topical application of honey in the management of radiation mucositis: a preliminary study. Support Care Cancer. 2003 Apr;11(4):242-8. doi: 10.1007/s00520-003-0443-y. Epub 2003 Feb 19.

  PMID: 12673463 BACKGROUND

• Bossola M. Xerostomia in patients on chronic hemodialysis: An update. Semin Dial. 2019 Sep;32(5):467-474. doi: 10.1111/sdi.12821. Epub 2019 May 22.

  PMID: 31117154 BACKGROUND

• Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.

  PMID: 15458464 BACKGROUND

• Bots CP, Brand HS, Veerman EC, Korevaar JC, Valentijn-Benz M, Bezemer PD, Valentijn RM, Vos PF, Bijlsma JA, ter Wee PM, Van Amerongen BM, Nieuw Amerongen AV. Chewing gum and a saliva substitute alleviate thirst and xerostomia in patients on haemodialysis. Nephrol Dial Transplant. 2005 Mar;20(3):578-84. doi: 10.1093/ndt/gfh675. Epub 2005 Jan 21.

  PMID: 15665029 BACKGROUND

• Breseghelo Mde L, Guillo LA, Nogueira TE, Leles CR. Nitric Oxide Concentration and Other Salivary Changes after Insertion of New Complete Dentures in Edentulous Subjects. Int J Dent. 2016;2016:8351427. doi: 10.1155/2016/8351427. Epub 2016 Feb 29.

  PMID: 27034674 BACKGROUND

• Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.

  PMID: 28279391 BACKGROUND

• Cho EP, Hwang SJ, Clovis JB, Lee TY, Paik DI, Hwang YS. Enhancing the quality of life in elderly women through a programme to improve the condition of salivary hypofunction. Gerodontology. 2012 Jun;29(2):e972-80. doi: 10.1111/j.1741-2358.2011.00594.x. Epub 2011 Nov 30.

  PMID: 22126433 BACKGROUND

• Dalodom S, Lam-Ubol A, Jeanmaneechotechai S, Takamfoo L, Intachai W, Duangchada K, Hongsachum B, Kanjanatiwat P, Vacharotayangul P, Trachootham D. Influence of oral moisturizing jelly as a saliva substitute for the relief of xerostomia in elderly patients with hypertension and diabetes mellitus. Geriatr Nurs. 2016 Mar-Apr;37(2):101-9. doi: 10.1016/j.gerinurse.2015.10.014. Epub 2015 Nov 26.

  PMID: 26631691 BACKGROUND

• Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.

  PMID: 20303025 BACKGROUND

• Villa A, Wolff A, Aframian D, Vissink A, Ekstrom J, Proctor G, McGowan R, Narayana N, Aliko A, Sia YW, Joshi RK, Jensen SB, Kerr AR, Dawes C, Pedersen AM. World Workshop on Oral Medicine VI: a systematic review of medication-induced salivary gland dysfunction: prevalence, diagnosis, and treatment. Clin Oral Investig. 2015 Sep;19(7):1563-80. doi: 10.1007/s00784-015-1488-2. Epub 2015 May 22.

  PMID: 25994331 BACKGROUND

• Vinke J, Kaper HJ, Vissink A, Sharma PK. Dry mouth: saliva substitutes which adsorb and modify existing salivary condition films improve oral lubrication. Clin Oral Investig. 2020 Nov;24(11):4019-4030. doi: 10.1007/s00784-020-03272-x. Epub 2020 Apr 17.

  PMID: 32303864 BACKGROUND

• Wolff A, Joshi RK, Ekstrom J, Aframian D, Pedersen AM, Proctor G, Narayana N, Villa A, Sia YW, Aliko A, McGowan R, Kerr AR, Jensen SB, Vissink A, Dawes C. A Guide to Medications Inducing Salivary Gland Dysfunction, Xerostomia, and Subjective Sialorrhea: A Systematic Review Sponsored by the World Workshop on Oral Medicine VI. Drugs R D. 2017 Mar;17(1):1-28. doi: 10.1007/s40268-016-0153-9.

  PMID: 27853957 BACKGROUND

• Yang G, Lin S, Wu Y, Zhang S, Wu X, Liu X, Zou C, Lin Q. Auricular Acupressure Helps Alleviate Xerostomia in Maintenance Hemodialysis Patients: A Pilot Study. J Altern Complement Med. 2017 Apr;23(4):278-284. doi: 10.1089/acm.2016.0283. Epub 2017 Feb 13.

  PMID: 28191857 BACKGROUND

• Yang LY, Chen HM, Su YC, Chin CC. The effect of transcutaneous electrical nerve stimulation on increasing salivary flow rate in hemodialysis patients. Oral Dis. 2019 Jan;25(1):133-141. doi: 10.1111/odi.12948. Epub 2018 Sep 9.

  PMID: 30076692 BACKGROUND

• Yang LY, Yates P, Chin CC, Kao TK. Effect of acupressure on thirst in hemodialysis patients. Kidney Blood Press Res. 2010;33(4):260-5. doi: 10.1159/000317933. Epub 2010 Jul 2.

  PMID: 20606475 BACKGROUND

• Yu IC, Tsai YF, Fang JT, Yeh MM, Fang JY, Liu CY. Effects of mouthwash interventions on xerostomia and unstimulated whole saliva flow rate among hemodialysis patients: A randomized controlled study. Int J Nurs Stud. 2016 Nov;63:9-17. doi: 10.1016/j.ijnurstu.2016.08.009. Epub 2016 Aug 20.

  PMID: 27565424 BACKGROUND

• Ibrahim SS, Abou-Bakr A, Ghalwash DM, Hussein RR. Effectiveness of thyme honey in the management of xerostomia in geriatric patients with end-stage renal disease: a randomized controlled clinical trial with a biochemical assessment. Eur J Med Res. 2023 Oct 7;28(1):406. doi: 10.1186/s40001-023-01351-9.

  PMID: 37805605 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment protocol: * Thyme honey will topically be applied to the oral mucosa as oral rinse based on the Biswal et al. (2003) administration protocol. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: February 18, 2022
• Study Start: September 10, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 10, 2021
• Last Updated: February 18, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)