Erythropoietin Gel as an Adjunct to Split-Thickness Apically Positioned Flap in Augmentation of Attached Gingiva

NCT05683782 | Unknown Phase 4

• 1 other identifier: Erythropoietin Gel
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be carried out to evaluate the effect of topical application of erythropoietin gel as an adjunct to split-thickness apically positioned flap regarding Wound Healing and the Effect on post-surgical symptoms \[ Patient Satisfaction\] (1ry objective) and Clinical gain in width of attached gingiva. (2ry objective).

Conditions

Erythropoietin; Recession

Outcome Measures

Primary Outcomes (2)

• Wound healing

  Using toluidine blue epithelialization test to asses the wound healing. The surgical site will be stained with toluidine blue stain. The darkly stained bluish patches will be interpreted as wound sites that are still healing and have insufficient surface epithelialization. The darkly stained areas will be photographed and then uploaded to a picture editing software to determine their surface area using digital tracing.

  21 days

• Patient Satisfaction

  By using a 10 cm horizontal visual analogue scale. The patients will be asked to rate the degree of pain Zero represents the least amount of pain and ten represents the most amount of pain.

  1 month

Secondary Outcomes (1)

• Width of Attached Gingiva

  1 month

Study Arms (2)

Test Group

ACTIVE COMPARATOR

Split-thickness Apically Positioned Flap with topical Erythropoietin (Test group): A split thickness horizontal incision will be done at the mucogingival junction of the targeted area to be augmented with a scalpel with blade number 15C. Around the teeth, the gingiva stays intact coronal to the horizontal incision. The horizontal incision will extend mesio-distally in accordance with the area to be augmented.(Mandibular anterior or premolar teeth). A split-thickness flap is elevated, and the dissection is extended as far as necessary in the apical direction. The flap is secured to the periosteum with simple interrupted bio absorbable sutures. A Chitosan based Erythropoietin gel will be prepared. 1 mL of EPO-loaded with chitosan 5% and β-glycerophosphate disodium salt (GP) 20% gel will be used. The patient will be instructed to use the gel on the surgical site two times daily for 14 days.

Drug: Split thickness Apically positioned flap with Chitosan based Erythropoietin Gel application

Control Group

ACTIVE COMPARATOR

Split-thickness Apically Positioned Flap without Erythropoietin : Local anesthesia is administered by infiltration technique. The same surgical procedure is performed with the application of Chitosan gel without being loaded with erythropoietin.

Drug: Split thickness Apically positioned flap without Erythropoietin application

Interventions

Split thickness Apically positioned flap with Chitosan based Erythropoietin Gel application DRUG

Split thickness Apically positioned flap will be performed to increase width of attached gingiva .1 mL of EPO-loaded with chitosan 5% and β-glycerophosphate disodium salt (GP) 20% gel will be used by the patient two times daily for 14 days.

Test Group

Split thickness Apically positioned flap without Erythropoietin application DRUG

Split thickness Apically positioned flap will be performed to increase width of attached gingiva.The patient will use a Chitosan gel without being loaded with erythropoietin two times daily for 14 days

Control Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females within age range of 20-40 years.
• Patients free of systemic diseases according to Burket's oral health history questionnaire .
• Patients who can follow and maintain oral hygiene instructions.
• Patients having insufficient width of attached gingiva (\<2mm) in labial aspect of lower anterior or premolar teeth and Miller Class I recession .
• Thick gingival phenotype.

You may not qualify if:

• Smokers.
• Pregnant and lactating females
• Unwillingness or inability to return for follow-up appointments
• High frenum attachment
• Crowding of test site teeth
• Vulnerable patients (those with mental or physical impairments).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11588, Egypt

RECRUITING

Related Publications (8)

• Yaghobee S, Rouzmeh N, Taheri M, Aslroosta H, Mahmoodi S, Mohammadnejad Hardoroodi M, Soleimanzadeh Azar P, Khorsand A. Evaluation of topical erythropoietin application on the healing outcome of gingival graft recipient site; a randomized controlled clinical trial. BMC Oral Health. 2021 Nov 12;21(1):578. doi: 10.1186/s12903-021-01948-8.

  PMID: 34772399 BACKGROUND

• Yaghobee S, Rouzmeh N, Aslroosta H, Mahmoodi S, Khorsand A, Kharrazifard MJ. Effect of Topical Erythropoietin (EPO) on palatal wound healing subsequent to Free Gingival Grafting (FGG). Braz Oral Res. 2018 Jun 11;32:e55. doi: 10.1590/1807-3107bor-2018.vol32.0055.

  PMID: 29898030 BACKGROUND

• Rezazadeh M, Jafari N, Akbari V, Amirian M, Tabbakhian M, Minaiyan M, Rostami M. A mucoadhesive thermosensitive hydrogel containing erythropoietin as a potential treatment in oral mucositis: in vitro and in vivo studies. Drug Deliv Transl Res. 2018 Oct;8(5):1226-1237. doi: 10.1007/s13346-018-0566-9.

  PMID: 30076521 BACKGROUND

• Hamed S, Belokopytov M, Ullmann Y, Safadi M, Stark Y, Shoufani A, Akita S, Liu PY, Teot L. Interim Results of the Remede d'Or Study: A Multicenter, Single-Blind, Randomized, Controlled Trial to Assess the Safety and Efficacy of an Innovative Topical Formulation of Erythropoietin for Treating Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2019 Oct 1;8(10):514-521. doi: 10.1089/wound.2018.0808. Epub 2019 Aug 21.

  PMID: 31832270 BACKGROUND

• Brines M, Cerami A. Erythropoietin-mediated tissue protection: reducing collateral damage from the primary injury response. J Intern Med. 2008 Nov;264(5):405-32. doi: 10.1111/j.1365-2796.2008.02024.x.

  PMID: 19017170 BACKGROUND

• Carnio J, Miller PD Jr. Increasing the amount of attached gingiva using a modified apically repositioned flap. J Periodontol. 1999 Sep;70(9):1110-7. doi: 10.1902/jop.1999.70.9.1110.

  PMID: 10505814 BACKGROUND

• Carnio J, Camargo PM, Passanezi E. Increasing the apico-coronal dimension of attached gingiva using the modified apically repositioned flap technique: a case series with a 6-month follow-up. J Periodontol. 2007 Sep;78(9):1825-30. doi: 10.1902/jop.2007.060414.

  PMID: 17760555 BACKGROUND

• Buemi M, Galeano M, Sturiale A, Ientile R, Crisafulli C, Parisi A, Catania M, Calapai G, Impala P, Aloisi C, Squadrito F, Altavilla D, Bitto A, Tuccari G, Frisina N. Recombinant human erythropoietin stimulates angiogenesis and healing of ischemic skin wounds. Shock. 2004 Aug;22(2):169-73. doi: 10.1097/01.shk.0000133591.47776.bd.

  PMID: 15257091 BACKGROUND

Study Officials

• Ahmed E Amr, Assoc.Prof

  Ain Shams University

  STUDY DIRECTOR

• Hala k Abdelgaber, Professor

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Dina M Fadl, bachelor

CONTACT

01113906814; dina.magdy.fadl92@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: January 13, 2023
• Study Start: October 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 13, 2023

Record last verified: 2022-12

Locations

EG (1)