Actively Recruiting

Phase 4
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06048042

Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects

Led by Cairo University · Updated on 2024-08-26

24

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main goal is to evaluate and compare the clinical and radiographic efficacy of autogenous demineralized dentin as bone graft substitute versus autogenous bone graft when performed with modified minimally invasive surgical technique (M-MIST) in the treatment of periodontal intrabony defects. The main question is: In periodontitis patients with intrabony defects, will using autogenous demineralized dentin as bone graft substitute result in clinical attachment gain and linear bone fill similar to autogenous bone graft following modified minimally invasive surgical technique? After enrolment, each participant with intra-bony defects will receive the initial phase of the therapy, which will include oral hygiene instructions, supragingival and subgingival debridement using ultrasonic and hand instrumentations and relieving of occlusal trauma if any. After 4-6 weeks, an individually customized positioning stent will be fabricated for each participant and a pre-operative periapical x-ray using parallel-angle technique will be employed using X-ray film holding system to ensure accuracy and reproducibility of the measurements. Criteria used to indicate that surgery is required include the persistence of interproximal defect with PD (Probing depth) ≥ 5 mm, CAL (Clinical attachment loss) ≥ 4 mm. Surgical procedures will include flap elevation for approaching the defect-associated sites using the modified minimally invasive surgical technique (M-MIST). Intervention group: The defect will be filled with autogenous demineralized dentin graft prepared from the participant's freshly extracted own teeth. Control group: The defect will be filled with autogenous bone graft harvested from the retromolar area. For both groups, flaps will be approximated and sutured at the original position. All the subjects will be evaluated at 1, 3, and 6 months for clinical and radiographic parameters. Outcomes:The results of Clinical attachment level (CAL) gain, Linear bone fill, Gingival index (GI), Plaque index (PI), Probing pocket depth (PPD), Gingival recession (GR), Bleeding on probing (BoP), Postoperative pain and Patient satisfaction will be measured at baseline, 1 month, 3 months and after 6 months.

CONDITIONS

Official Title

Evaluation of Autogenous Demineralized Dentin Graft Vs Autogenous Bone Graft in Management of Intrabony Defects

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Motivated patient 18 years of age or older
  • Patient consulting in the outpatient clinic
  • Patient ready to perform oral hygiene instructions
  • Provide informed consent
  • Accepts the 6 months follow-up period
  • Tooth with two or three-walled intra-bony defect with probing depth 25 5 mm and intraosseous defect 25 3 mm
  • Mature permanent tooth
  • Unrestorable tooth, fractured beyond restoration, impacted third molar, or supernumerary tooth to be extracted and used as graft inside the intrabony defect
Not Eligible

You will not qualify if you...

  • Medically compromised patients
  • Pregnant women
  • Uncooperative patients
  • Smokers
  • Systemic diseases that may compromise healing or bone metabolism (e.g., diabetes, hyperthyroidism)
  • Failure to maintain good oral hygiene
  • Teeth with supra-bony defects
  • Teeth with grade III mobility
  • Teeth with interproximal craters, grade III furcation involvement, and grade III mobility
  • Presence of caries or overhanging restorations
  • Presence of peri-apical injuries

AI-Screening

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

G

Ghada M. Abouhussein, Bachelor

CONTACT

N

Nesma Shemais, Ass Lecturer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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