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

Sponsor

Mansoura University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06041854

Collaborator

(none)

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intrabony Periodontal Defect	Procedure: Freeze-dried bone allograft combined with Enamel Matrix derivative Procedure: Freeze-dried bone allograft	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Test group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograftTest group will receive EMD mixed with freeze-dried bone allograft, Control group will receive freeze-dried bone allograft

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 22, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Radiographic bone defect fill [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)

Secondary Outcome Measures

Clinical attachment level [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
Probing pocket depth [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.
Plaque Index [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.
Gingival Bleeding Index [GBI will be measured at base line, 3, 6, 9 months postoperative]
GBI will be measured according to Ainamo & Bay (1975)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura		Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Jilan Youssef, Professor, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rouida nouri, M.Sc. - Master Degree of Oral Medicine & Clinical Periodontology, Mansoura University

ClinicalTrials.gov Identifier:

NCT06041854

Other Study ID Numbers:

A02040122

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 21, 2023