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

September 16, 2023 updated by: Rouida nouri, Mansoura University

Comparison Between Allograft and Enamel Matrix Derivative and Allograft in Treatment of Intrabony Defects

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

primary goal of periodontal therapy is not arrest the tissue destruction caused periodontal disease only, but also to reconstruct the tissue lost caused by infectious process. 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. Surgical intervention is considered the treatment of choice for deep intrabony defects, which have not resolved following completion of cause-related periodontal therapy.

In general, periodontal studies showed that healing of periodontal defect after conventional periodontal therapy by collagenous tissue with epithelial cell migration within the gingival connective tissue and along the root surface. Therefore, a various of methods and techniques used to prevent epithelial ingrowth to the defect site and permit only a selective periodontal cells proliferation in attempt to regenerate periodontal tissues. Regenerative procedures including the use of certain types of bone replacement materials, barrier membranes, enamel matrix derivative (EMD), or various combinations thereof have been shown to facilitate periodontal regeneration characterized histologically by formation of root cementum, periodontal ligament, and alveolar bone and result superior in clinical, and radiographical patient reported outcomes compared to access flap surgery alone.

Various bone graft and bone substitutes materials can be helpful in the tissue restoration. This bone graft include autogenous bone graft, allografts, xenografts, and alloplastic materials. Autologous bone is considered the gold standard because of its biological activity due to vital cells and growth factors. Yet, the autologous bone from intra-oral donor sites is of restricted quantities and availability, and the bone tissue obtained from the iliac crest is described to show faster resorption. Moreover, the harvesting of autologous bone often requires a second surgical site associated with an additional bone defect, potential donor site morbidity limiting their application.

In recent years, the use of allogeneic human bone has been favored worldwide, and several histological and morphological studies have demonstrated that, there is no difference in the final stage of incorporation and new bone formation between allografts and autografts. Thus, the application of processed allogenic bone tissue is a reliable and predictable alternative.

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.

Maxgraft® is allograft bone substitute processed by the Cells+Tissuebank Austria with a special cleaning process (Allotec® process). The purification process keeps the structural features and the interconnected macroporosity of human bone. It preserve natural bone structure and collagen content, therefore it serves as a scaffold for natural bone regeneration and has the potential of complete remodeling into patients' own bone. It is available as purely cancellous as well as cortico-cancellous granules and blocks.

Recently, better outcomes have been reported with a combination of xenograft and enamel matrix derivative (EMD) as it combines the osteoconductive and space-making properties of bone grafts with the ability of bioactive materials to stimulate periodontal regeneration. 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.

To the best of our knowledge, no previous studies have been performed for assessment of the efficacy of using emdogain with maxgraft.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Mansoura University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: freeze-dried bone allograft combined with enamel matrix derivative
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

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.
Active Comparator: freeze-dried bone allograft
The intrabony defects will be treated by surgical treatment and the defects filled by freeze-dried bone allograft.
Procedure: Freeze-dried bone allograft

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic bone defect fill
Time Frame: at baseline and 9 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: CAL will be measured at base line, 3, 6, 9 months postoperative
CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth
CAL will be measured at base line, 3, 6, 9 months postoperative
Probing pocket depth
Time Frame: PD will be measured at base line, 3, 6, 9 months postoperative
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.
PD will be measured at base line, 3, 6, 9 months postoperative
Plaque Index
Time Frame: PI will be measured at base line, 3, 6, 9 months postoperative
Plaque index will be taken as an indicator for the patient oral hygiene.
PI will be measured at base line, 3, 6, 9 months postoperative
Gingival Bleeding Index
Time Frame: GBI will be measured at base line, 3, 6, 9 months postoperative
GBI will be measured according to Ainamo & Bay (1975)
GBI will be measured at base line, 3, 6, 9 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Jilan Youssef, Professor, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A02040122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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