Allograft With Enamel Matrix Derivative Versus Allograft Alone in the Treatment of Intrabony Defects .

NCT06041854 | Completed DMC

• 1 other identifier: A02040122
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontal intrabony defects represent a major challenge for the clinician in periodontal therapy. If left untreated, these defects represent a risk factor for disease progression and additional attachment and bone loss. All patients will receive full mouth scaling and root planing and be re-evaluated to assess patient cooperation and maintaining good oral hygiene. Subjects who showed persistent PPD ≥ 5 mm with radiographic evidence of periodontal intrabony defect presence will be included and will be randomly allocated to one of two treatment groups.One group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative. second group will be treated by surgical treatment and the defects filled by freeze-dried bone allograft .Clinical periodontal parameters (PI, GBI, PPD, CAL) will be re-evaluated at 3, 6 and 9 months after surgery. CBCT will be taken after 9 months of surgery and the defect measurements will be recorded

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• Radiographic bone defect fill

  Cone Beam Computed Tomography (CBCT) will be taken prior to periodontal surgery and after 9 months. The amount of reduction in the IBD measurements (defect resolution)

  at baseline and 9 months

Secondary Outcomes (4)

• Clinical attachment level

  CAL will be measured at base line, 3, 6, 9 months postoperative

• Probing pocket depth

  PD will be measured at base line, 3, 6, 9 months postoperative

• Plaque Index

  PI will be measured at base line, 3, 6, 9 months postoperative

• Gingival Bleeding Index

  GBI will be measured at base line, 3, 6, 9 months postoperative

Study Arms (2)

freeze-dried bone allograft combined with enamel matrix derivative

EXPERIMENTAL

The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft mixed with enamel matrix derivative.

Procedure: Freeze-dried bone allograft combined with Enamel Matrix derivative

freeze-dried bone allograft

ACTIVE COMPARATOR

The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft.

Procedure: Freeze-dried bone allograft

Interventions

Freeze-dried bone allograft combined with Enamel Matrix derivative PROCEDURE

The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft mixed with enamel matrix derivative. Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle.The major components of EMD are amelogenins, a family of hydrophobic porcine tooth-derived proteins. They account for more than 95% of the total EMD protein content. Other proteins found in the enamel matrix include enamelin, ameloblastin, amelotin, apin and various proteinases, which have found in trace amounts in EMD. EMD adsorbs on decontamined root surfaces and alveolar bony defects and forms an insoluble scaffold complex.

freeze-dried bone allograft combined with enamel matrix derivative

Freeze-dried bone allograft PROCEDURE

The intrabony defects will be treated by minimally invasive surgical technique or modified minimally invasive surgical technique depending on defect extension, and the defects will be filled by freeze-dried bone allograft . Allogeneic bone graft refers to bony tissue that is harvested from one individual and transplanted to a genetically different individual of the same species, principally osteoconductive, although it may have some osteoinductive capability, depending on how it is processed.

freeze-dried bone allograft

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range between 30-50 years.
• Patients with stage III periodontitis, will be diagnosed on the basis of probing pocket depth and clinical attachment loss.
• Presence of at least one or more radiographically detectable intrabony defect with clinical periodontal pocket depth (PPD) ≥5 mm, clinical attachment loss ≥5 mm, and radiographic depth of the intrabony defect ≥3 mm.
• No periodontal therapy within the last 6 months

You may not qualify if:

• Smoker and alcoholic patient.
• Patient with any signs, symptoms or history of systemic disease that might affect the periodontium and interfere with healing process.
• Pregnant patients.
• Patient who has traumatic occlusion.
• Uncooperative patient

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

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Study Officials

• Jilan Youssef, Professor

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. - Master Degree of Oral Medicine & Clinical Periodontology

Model Details: Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: November 22, 2022
• Primary Completion: November 22, 2023
• Study Completion: February 22, 2024
• Last Updated: May 21, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)