Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.

NCT06842368 | Recruiting

• 1 other identifier: A.M.A.E
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region

Conditions

Immediate Implant Placement

Keywords

Hyaluronic acid; Vitamin D; Xenograft; Immediate Implant

Outcome Measures

Primary Outcomes (1)

• Implant secondary stability

  To evaluate the implant stability by Any-check device.

  after 6 months

Secondary Outcomes (1)

• Density of bone around implant

  after 6 months

Study Arms (2)

Vitamin D mixed with Xenograft as space filling material after placement of immediate implant.

EXPERIMENTAL

Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with Vitamin D and the socket will sealed using 4-0 resorbable sutures.

Procedure: Vitamin D

Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant.

ACTIVE COMPARATOR

Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid and the socket will sealed using 4-0 resorbable sutures.

Procedure: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) PROCEDURE

Hyaluronic acid is one of the essential components of extracellular matrix, which plays a predominant role in tissue morphogenesis, cell migration, differentiation, and adhesion. It has been recently reported that hyaluronic acid increases osteoblastic bone formation in vitro through increased mesenchymal cell differentiation and migration. It has demonstrated that Hyaluronic acid not only acted as a carrier of growth factors and cell but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts. Although Hyaluronic acid shares bone induction properties with growth factors as bone morphogenic protein 2 and osteopontin

Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant.

Vitamin D PROCEDURE

It was shown that locally applied vitamin D3 in combination with bovine bone mineral matrix improved the bone formation and strengthened the site of the fracture in ovariectomized rats. Local application of vitamin D3 also proved to be promising in promoting osteo- genesis and mineralization for restoration of bone defects. Grounding on this incites, it has been suggested that vitamin D3 might exert a positive local effect on alveolar bone regeneration

Vitamin D mixed with Xenograft as space filling material after placement of immediate implant.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60.
• Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth region.
• Absence of any peri-apical pathosis.
• Patients with intact buccal plate of bone.
• Patients with adequate bone volume for the dental implant procedure.
• Patient with good oral hygrine

You may not qualify if:

• Heavy Smokers.
• Systemic disease that may affect the final outcome of the surgical procedure.
• No or poor patient's compliance.
• Patients with psychological problems.
• Pathology at the site of intervention.
• Patient with vit d deficiency

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry ,Cairo university

Cairo, Egypt

RECRUITING

Related Publications (2)

• Abd Elwahap, Mohammad et al. "Effect of Xenograft Alone versus Xenograft Mixed with Vitamin-D On Preservation of Alveolar Sockets of Chronically Infected Teeth." Al-Azhar Journal of Dental Science (2024): n. pag.

  BACKGROUND

• ⦁ Elgazzar, A., Yousef, E., Amer, M. Effect of Hyaluronic Acid Mixed with Biphasic Calcium Phosphate on Bone Healing Around Immediately Placed Implants in the Posterior Area of the Mandible. Egyptian Dental Journal, 2023; 69(4): 2631-2641. doi: 10.21608/edj.2023.227200.2669

  BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acid; Vitamin D

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

AMMAR EIZ EDDIN

CONTACT

00201153383058; ammar.adib@dentistry.cu.edu.eg

MOHAMED ASHRAF, phD

CONTACT

00201111186256; mohamed-ashraf@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree candidate

Model Details: Randomized Controlled Clinical Trial. Parallel group study. Allocation Ratio 1:1.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 24, 2025
• Study Start: February 2, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

EG (1)