Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects

NCT05360511 | Completed Early Phase 1

• 1 other identifier: EPO In periodontitis
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the use of erythropoietin gel as an adjunct to xenograft in the surgical management of intrabony periodontal defects.

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (10)

• Evaluation of Plaque index (PI):

  it will be described by a number on a scale from 0 to 5 as follows: 0 = No plaque.1 = Separate flecks of plaque present at the cervical margin.2 = A thin, continuous band of plaque.3 = A band of plaque wider than 1 mm.4 = Plaque affecting at least 1/3, but not 2/3 of the side of the crown.5 = Plaque affecting 2/3 or more of the side of the crown.

  at baseline (before the surgery by one week)

• Evaluation of Plaque index (PI):

  it will be described by a number on a scale from 0 to 5 as follows: 0 = No plaque.1 = Separate flecks of plaque present at the cervical margin.2 = A thin, continuous band of plaque.3 = A band of plaque wider than 1 mm.4 = Plaque affecting at least 1/3, but not 2/3 of the side of the crown.5 = Plaque affecting 2/3 or more of the side of the crown.

  6 months after the surgery.

• Evaluation of the Sulcus bleeding index (SBI):

  it will be described by a number on a scale from 0 to 5 as follows: 0: No inflammation; no bleeding on probing. 1. = Bleeding on gentle probing; tissue appears normal. 2. = Bleeding on probing and change in color due to inflammation. 3. = Bleeding on probing, change in color and slight edema. 4. = Bleeding on probing, color change, and obvious edema. 5. = Bleeding on probing and spontaneous bleeding, also color change and obvious edema.

  at baseline (before the surgery by one week)

• Evaluation of the Sulcus bleeding index (SBI):

  it will be described by a number on a scale from 0 to 5 as follows: 0: No inflammation; no bleeding on probing. 1. = Bleeding on gentle probing; tissue appears normal. 2. = Bleeding on probing and change in color due to inflammation. 3. = Bleeding on probing, change in color and slight edema. 4. = Bleeding on probing, color change, and obvious edema. 5. = Bleeding on probing and spontaneous bleeding, also color change and obvious edema.

  6 months after the surgery.

• Evaluation of the probing depth :

  it will be measured from the gingival margin to the depth of the periodontal pocket using a periodontal probe in millimeters.

  at baseline (before the surgery by one week)

• Evaluation of the probing depth :

  it will be measured from the gingival margin to the depth of the periodontal pocket using a periodontal probe in millimeters.

  6 months after the surgery.

• Evaluation of the clinical attachment level :

  it will be measured from the cemento-enamel junction to the depth the periodontal pocket by periodontal probe in millimeters.

  at baseline (before the surgery by one week)

• Evaluation of the clinical attachment level :

  it will be measured from the cemento-enamel junction to the depth the periodontal pocket by periodontal probe in millimeters.

  6 months after the surgery.

• Evaluation of healing.

  it will be evaluated by the Early Healing Index (EHI) on a scale from 1 to 5 as follows: 1. = complete flap closure - no fibrin line in the interproximal area. 2. = complete flap closure - fine fibrin line in the interproximal area 3= complete flap closure - fibrin clot in the interproximal area. 4 = incomplete flap closure - partial necrosis of the interproximal tissue. 5 = incomplete flap closure - complete necrosis of the interproximaltissue.

  one week after the surgery.

• Evaluation of healing.

  it will be evaluated by the Early Healing Index (EHI) on a scale from 1 to 5 as follows: 1. = complete flap closure - no fibrin line in the interproximal area. 2. = complete flap closure - fine fibrin line in the interproximal area 3= complete flap closure - fibrin clot in the interproximal area. 4 = incomplete flap closure - partial necrosis of the interproximal tissue. 5 = incomplete flap closure - complete necrosis of the interproximaltissue.

  two weeks after the surgery.

Secondary Outcomes (2)

• Radiographic assessment .

  at baseline (before the surgery by one week)

• Radiographic assessment .

  6 months after the surgery.

Study Arms (2)

Group A (Test group)

EXPERIMENTAL

Group A (Test group): Twelve patients will be subjected to open flap debridement and application of particulate xenograft + erythropoietin gel.

Drug: particulate xenograft + erythropoietin gel.

Group B (Control group)

ACTIVE COMPARATOR

Group B (Control group): Twelve patients will be subjected to open flap debridement and application of particulate xenograft.

Combination Product: particulate xenograft

Interventions

particulate xenograft + erythropoietin gel. DRUG

1. Surgical sites will be anaesthetized using local anaesthesia. 2. Intrasulcular incision will be done in the periodontal pocket as close as possible to the tooth surface with the deepest point being the alveolar crest. 3. The incisions will be extended to the mesial papilla of the tooth before the defect and the distal papilla of the tooth after the defect. 4. Both buccal and lingual/palatal mucoperiosteal flaps will be raised using blunt dissection. 5. Mechanical debridement of the infected tissue from the intrabony defect and root debridement will be done using Gracey curettes. * In Group A (test group): Particulate xenograft will be mixed with EPO gel and applied to fill the whole defect.

Also known as: The mix of xenograft and EPO gel

Group A (Test group)

particulate xenograft COMBINATION_PRODUCT

* All surgeries will be performed by the same operator as follows: 1. Surgical sites will be anaesthetized using local anaesthesia. 2. Intrasulcular incision will be done in the periodontal pocket as close as possible to the tooth surface with the deepest point being the alveolar crest. 3. The incisions will be extended to the mesial papilla of the tooth before the defect and the distal papilla of the tooth after the defect. 4. Both buccal and lingual/palatal mucoperiosteal flaps will be raised using blunt dissection. 5. Mechanical debridement of the infected tissue from the intrabony defect and root debridement will be done using Gracey curettes. * In Group B (control group): Particulate xenograft will be applied to fill the whole defect.

Also known as: The xenograft alone

Group B (Control group)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders within age range of 20-50 years.
• Patients diagnosed with periodontitis (Stage III).
• Test site criteria: probing pocket depth ≥6mm and CAL ≥3mm. All these criteria will be determined after phase I conventional periodontal therapy.
• Patients with three-wall intrabony defect.
• Systemically free patients as evidenced by Burket's oral health history questionnaire .
• Ability to attend the treatment sessions and comply with its procedures, the recall visits and oral hygiene protocol.

You may not qualify if:

• Smokers.
• Pregnant or lactating females.
• Patients under any medication that affect periodontal healing.
• Vulnerable individuals

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry , Ain Shams University.

Cairo, Egypt

Location

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MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Amr, Professor

  Ain Shams University

  STUDY DIRECTOR

• yasmin El Sayed, lecturer

  Ain Shams University

  STUDY DIRECTOR

• Mahmoud Mousa, lecturer

  MSA University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: May 4, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

EG (1)