Intrabony Defects in Chronic PeriodontitisNCT06699043
Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique
A study testing nanocrystalline hydroxyapatite in putty form and Demineralized Bone Matrix allograft putty in people with Intrabony Defects in Chronic Periodontitis, run by Afaf Mansour Dao Abdelslam at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Defects in Chronic Periodontitis
- What is being tested?
- nanocrystalline hydroxyapatite in putty form and Demineralized Bone Matrix allograft putty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry , Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Comparative Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique (Clinical, Radiographical and Histological Evaluation)
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
Read more
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
Read the 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:
- 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
- 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
- Being tested
- nanocrystalline hydroxyapatite in putty form, Demineralized Bone Matrix allograft putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanocrystalline hydroxyapatite in putty formProcedure or surgery
Also called guidede tissue regeneration
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 puttyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Demineralized Bone Matrix allograft putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical (Clinical attachment level CAL)
It was measured since the CEJ to the base of the pocket with UNC-15 periodontal probe
Measured: 3,6,12 months
Radiographical Analysis of bone defect
Assessment of bone defect area by digital intraoral periapical (IOPA) radiographs.
Measured: at baseline, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jun 2024
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Defects in Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afaf Mansour Dao Abdelslam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Afaf Mansour Dao Abdelslam, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699043
- Sponsor's protocol ID
- M0104023OM
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it will be decided during the publication times as it may be provided as supplementary files
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique (Clinical, Radiographical and Histological Evaluation)
- ClinicalTrials.gov ID
- NCT06699043
- Acronym / sponsor ID
- M0104023OM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Afaf Mansour Dao AbdelslamUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| nanocrystalline hydroxyapatite in putty form | Active comparator | Procedure: 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. |
| Demineralized Bone Matrix allograft putty as grafting material | Active comparator | Procedure: Demineralized Bone Matrix allograft puttygroup 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nanocrystalline hydroxyapatite in putty formAlso: guidede tissue regenerationdecortication 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). | Procedure or surgery | nanocrystalline hydroxyapatite in putty form |
| Demineralized Bone Matrix allograft puttydecortication 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. | Procedure or surgery | Demineralized Bone Matrix allograft putty as grafting material |
Primary outcome
Clinical (Clinical attachment level CAL)
Time frame: 3,6,12 months
It was measured since the CEJ to the base of the pocket with UNC-15 periodontal probe
Radiographical Analysis of bone defect
Time frame: at baseline, 6, 12 months
Assessment of bone defect area by digital intraoral periapical (IOPA) radiographs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Undecided. it will be decided during the publication times as it may be provided as supplementary files
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nanocrystalline hydroxyapatite in putty form and Demineralized Bone Matrix allograft putty in people with Intrabony Defects in Chronic Periodontitis, run by Afaf Mansour Dao Abdelslam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical (Clinical attachment level CAL) (time frame: 3,6,12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.