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

NCT ID: NCT06699043

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-30

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:

1. Plaque Index (PI).

2. Gingival Index (GI).

3. Clinical Attachment Level (CAL)

4. 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

Detailed Description

Inclusion criteria:

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 radiograpgh patients who had not periodontal therapy in the previous 6 months.

Exclusion criteria:

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.

Clinical assessment:

including the following parameters: Plaque Index according to Silness P. Loe H 1964. 2. Gingival Index according Loe Silness 1963. 3. Probing pocket depth (PPD) is measured from the free gingival margin to the base of the pocket. 4. Clinical attachment level (CAL) is measured from the cement enamel junction to the base of the pocket.

• In patients All clinical assessments will be recorded at the baseline (immediate before surgery) and after 3 ,6 and 12months post-surgery and radiographic assessments will be recorded at the baseline and after 6 and 12months post-surgery.

This study was conducted following guidelines regulating research work on human subjects of the Faculty of Dentistry, Mansoura University, and the study protocol was reviewed and approved by the Research Ethics Committee of the Faculty of Dentistry, Mansoura University, Egypt. (Number:M0104023OM) All study subjects will sign written informal consent form before enrollment.

Materials:

1. nanocrystalline hydroxyapatite in putty form (NanoBone® SBX Putty) is a unique and patented advanced bone grafting material. It incorporates nano-crystalline particles of hydroxyapatite (HA) that are similar in size, chemistry, and morphology to HA particles occurring in human bone. It is Synthetic biodegradable bone graft substitute consisting of non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix embedded in an aqueous gel

2. Demineralized Bone Matrix allograft (DBM Putty). presurgical phase:

• Patients informed consents will be obtained prior to any periodontal treatment.
• Initial therapy includes full mouth supra and subgingival debridement using ultrasonic scalers and curettes
• and oral hygiene instruction will be given to all patients in the form of tooth brushing instructions and the use of chlorhexidine mouth wash 2 time daily for 2 weeks.
• After 4 weeks of initial therapy, all patients will be evaluated to ensure the behavior fitness for periodontal surgery.

surgical phase:

• Prior to surgery all patients will be given pre surgical rinse of 0.2 % Chlorhexidine for 30 seconds.
• The operative site will be anaesthetized using local anesthesia, Buccal and lingual crevicular incisions will be made.
• mucoperiosteal flaps will be reflected, the defect will be thoroughly debridement and root planning will be performed.
• The surgical area will be carefully irrigated with saline and root biomodification will be done.
• For both groups, 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).
• Group II will be treated similarly as Group I and the same surgical protocol will followed except that the intrabony defects 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.

post-surgical phase:

• Non-steroidal anti-inflammatory drug and antibiotics will be prescribed.
• chlorhexidine digluconate rinses (0.12%) twice daily for 2 weeks.
• Patients will be advised to consume only soft food during the first week.
• After this period, patients will be reinstructed in mechanical cleaning of the treated teeth using a soft toothbrush and roll technique of brushing for 1 month.
• Sutures will be removed 10 days post operatively. All the patients will be recalled at 3, 6 and 12 months for periodic rechecking.

Statistical Analysis:

All data will be calculated and analyzed by suitable statistical tests

Conditions

Intrabony Defects in Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nanocrystalline hydroxyapatite in putty form

• 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 Type: ACTIVE_COMPARATOR

nanocrystalline hydroxyapatite in putty form

Intervention Type: 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).

Demineralized Bone Matrix allograft putty 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.

Group Type: ACTIVE_COMPARATOR

Demineralized Bone Matrix allograft putty

Intervention Type: 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.

Interventions

nanocrystalline hydroxyapatite in putty form

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).

Intervention Type: PROCEDURE

Demineralized Bone Matrix allograft putty

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.

Intervention Type: PROCEDURE

Other Intervention Names

guidede tissue regeneration

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afaf Mansour Dao Abdelslam

OTHER

Sponsor Role: lead

Responsible Party

Afaf Mansour Dao Abdelslam

principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Dentistry , Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

M0104023OM

Identifier Type: -

Identifier Source: org_study_id