Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique

NCT06699043 | Active Not Recruiting

• 1 other identifier: M0104023OM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

to evaluate and compare efficacy of two different putty forms for both Demineralized Bone Matrix allograft (DBM) and nanocrystalline hydroxyapatite (NCHA) in treatment of intrabony defects with the aid of intramarrow penetration, A total of twenty patients will be diagnosed with stage III grade B periodontitis according to the Caton classification. They will be selected from the clinic of Department of Periodontology and Oral Medicine, Faculty of Dentistry, Mansoura University Patients will be classified into two groups:

• Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material.
• Group II: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material. Clinical assessment: including the following parameters:
• Plaque Index (PI).
• Gingival Index (GI).
• Clinical Attachment Level (CAL)
• Probing Depth (PD) Radiological parameters
• The height of the defect: Distance from the CEJ to the alveolar crest (AC)
• Depth of the defect: Distance from CEJ to the base of the defect
• Width of the defect: Highest point of the AC to the root adjacent to the defect
• Defect angle: Two lines that represent the root surface of the involved tooth and the bone defect surface

Conditions

Intrabony Defects in Chronic Periodontitis

Outcome Measures

Primary Outcomes (2)

• Clinical (Clinical attachment level CAL)

  It was measured since the CEJ to the base of the pocket with UNC-15 periodontal probe

  3,6,12 months

• Radiographical Analysis of bone defect

  Assessment of bone defect area by digital intraoral periapical (IOPA) radiographs.

  at baseline, 6, 12 months

Study Arms (2)

nanocrystalline hydroxyapatite in putty form

ACTIVE COMPARATOR

• Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material.

Procedure: nanocrystalline hydroxyapatite in putty form

Demineralized Bone Matrix allograft putty as grafting material

ACTIVE COMPARATOR

group II in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material.

Procedure: Demineralized Bone Matrix allograft putty

Interventions

nanocrystalline hydroxyapatite in putty form PROCEDURE

decortication will be performed by penetrating the cortical walls of the intrabony defect by using a round carbide bur of 0.2 mm diameter to reach the marrow space. * Multiple perforations will performed not closer than 1mm from each other and deep enough to obtain bleeding from the spongiosa * The intrabony defects in Group I will be received nanocrystalline hydroxyapatite in putty form as grafting material (NanoBone® SBX Putty).

Also known as: guidede tissue regeneration

nanocrystalline hydroxyapatite in putty form

Demineralized Bone Matrix allograft putty PROCEDURE

decortication will be performed by penetrating the cortical walls of the intrabony defect by using a round carbide bur of 0.2 mm diameter to reach the marrow space. • Multiple perforations will performed not closer than 1mm from each other and deep enough to obtain bleeding from the spongiosa • The intrabony defects in Group II will be received Demineralized Bone Matrix allograft putty as grafting material, in both groups will be use membrane to cover of the graft materials and finally will be sutured the flap.

Demineralized Bone Matrix allograft putty as grafting material

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders with 25-55 years of age.
• Patients with intrabony defects in the Stage III Grade B periodontitis.
• Individuals with probing depth ≥ 5mm.
• Individuals with clinical attachment loss ≥ 5mm.
• Presence of at least one or more intrabony defect ≥ 3 mm on the radiographs.
• patients who had not periodontal therapy in the previous 6 months.

You may not qualify if:

• Patient with stage I, II and IV periodontitis.
• Pregnant or lactating mothers.
• Patients having any systemic disease.
• allergies to Local anesthesia and chlorhexidine, antibiotics, and analgesics will be excluded.

Sponsors & Collaborators

• Afaf Mansour Dao Abdelslam: lead

Study Sites (1)

Faculty of Dentistry , Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator

Model Details: A total of twenty patients will be diagnosed with stage III grade B periodontitis according to the Caton classification. They will be selected from the clinic of Department of Periodontology and Oral Medicine, Faculty of Dentistry, Mansoura University Patients will be classified into two groups: * Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material. * Group II: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 21, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

EG (1)