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Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation

The Effect of Allogenic Demineralized Dentin Matrix (ADDM) on healing outcome in maxillary sinus floor augmentation (Histological and Radiological examination):Clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241127063872N1
Enrollment
38
Registered
2025-01-02
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Candidate patients for implant placement in the posterior region of the maxilla and maxillary sinus floor augmentation surgery.

Interventions

Intervention 1: **Intervention Group:**In the surgical procedure for the intervention group, 2 cc of allogenic demineralized dentin matrix is placed. Teeth with a poor prognosis (such as non-functioni
enamel is removed with a burr.The remaining dentin is rinsed with sterile saline and processed in a bone mill to create particles sized 1 to 1.5 mm. These particles are washed in a 0.1 M sodium chlori
Nova Teb Pars, Marzanabad, Iran) is placed.

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The height of the remaining bone between the alveolar crest and the sinus floor 5mm or less Presence of bilateral partial edentulism or complete edentulism in the posterior maxillary region

Exclusion criteria

Exclusion criteria: Pathological condition involving the sinus (cystic lesions , acute and chronic inflammatory disease and benign and malignant tumors) Medical conditions known to affect bone metabolism such as osteoporosis Drug regimen that affects the normal wound healing process ;Such as bisphosphonates and continuous use of corticosteroids History of chemotherapy or head and neck Radiotherapy at the time of surgery or the next 6 months Psychological problem that causes the patient's cooperation Sinus membrane perforation during surgery Smoking Pregnant women Systemic diseases such as uncontrolled diabetes and cardiovascular disease Presence of untreated periodontal diseases and periapical lesions in the teeth adjacent to the sinus

Design outcomes

Primary

MeasureTime frame
The amount of newly formed vital bone. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of newly formed vital bone is measured in square millimeters.;Amount of remaining grafting material. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Sampling is done with a Trephine bur with a diameter of 7.2 mm at the location of the implants. The collected samples are placed in 10% formalin solution and sent to the laboratory for histological examination. After routine and specific staining (Eosin and Hematoxylin and Red Alizarin), microscopic slides are prepared and after imaging with the help of Motic Image 2 software, the amount of the remaining graft material is measured in square millimeters.;Bone density. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: Based on the Hounsfield number From the CBCT by soft App Mimics 10.01.;Bone height. Timepoint: 6 months after maxillary sinus floor augmentation surgery. Method of measurement: The difference in bone height from the crest of the ridge to the bottom of the sinus between before surgery and 6 months after surgery in the patient's CBCT.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Aghaziarati

Tabriz University of Medical Sciences

faa.ziarati2@gmail.com+98 41 3334 6977

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026