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Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty

Minimally Invasive Non-surgical Therapy With or Without Injectable Bone Putty in Treating Intra-bony Periodontal Defects (Randomized Controlled Clinical Trial)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06553222
Enrollment
30
Registered
2024-08-14
Start date
2024-11-04
Completion date
2025-12-04
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Bone Defects

Keywords

periodontal bone defect -bone putty -infrabony defect

Brief summary

• All periodontitis patients with infra bony pockets to be included in this study will diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm will be treated by minimally invasive non-surgical therapy or by injectable bone putty

Detailed description

The present study will be designed as a randomized controlled clinical and radiographic. The study will be carried out on stage III grade (B) periodontitis patients with intra-bony defects. Those patients will be selected from the outpatient clinics of the Department of Oral Medicine and Periodontology, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. The study has bee approved by the ethical committee, Faculty of Dental medicine, Al-Azhar University, Assiut branch. 2\. All patients will be fully informed about the study's nature and the possible risks of the study procedures; they sign the consent form before the work.

Interventions

BIOLOGICALPutty bone - Tricalcium phosphate with Collagen gel

Minimally invasive debridement periodontal flap and Bone graft placement to augment the lost alveolar bone

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the outcome assessor will assess the bone gain (Radiographic) and Clinical attachment level (clinical) in both groups. the assessor is blinded whether a graft was loaded at the time of surgery

Intervention model description

2 parallel groups study group - The interventional group where minimally invasive debridement flap and a putty bone graft is tested and the Control group - where minimally invasive debridement flap is performed without graft

Eligibility

Sex/Gender
ALL
Age
35 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* • All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm. * 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability * All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings.

Exclusion criteria

• Any patients with any systemic condition that contraindicate any surgical intervention

Design outcomes

Primary

MeasureTime frameDescription
Primary outcomemeasured at 6 and 12 months postoperativemeasurement (mm) in alveolar bone gain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026