Clinical Comparison of Xenograft With Hydrogel Versus Xenograft Alone in the Socket Preservation After Tooth Extraction: A Randomized Controlled Clinical Trial

NCT06957197 | Not Yet Recruiting Phase 3

• 1 other identifier: Hydrogel in SocketPreservation
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Comparison of xenograft with hydrogel versus xenograft alone in the socket preservation After tooth extraction: A Randomized controlled Clinical Trial The ideal scaffolds used for alveolar ridge preservation are supposed to show good biocompatibility, mechanical properties, and formability for irregularly shaped bone defects, as well as degradation rates matching bone growth . One of the most used synthetic scaffolds is hydrogel. Hydrogels owning three-dimensional cross-linked network structures have physical and chemical properties like human tissues . They can not only simulate the extracellular matrix (ECM) of bone but also allow the storage, and transport of various growth factors, cytokines, and nutrients due to their high permeability .

Conditions

Socket Perservation

Outcome Measures

Primary Outcomes (1)

• Quantity of bone (bone height)

  Method of Measurement ;Radiographically Unit of Measurement ;mm

  3 mounths

Secondary Outcomes (6)

• Quantity of bone (bone width)

  3 mounths

• Quality of bone

  3 mounths

• Pain value

  1 week

• Infection

  1 week

• Edema

  1 week

Study Arms (2)

intervention

EXPERIMENTAL

socket preservation via hydrogel + xenograft

Drug: Hydrogel with xenograft

control

ACTIVE COMPARATOR

socket preservation via xenograft alone

Drug: Xenograft

Interventions

Hydrogel with xenograft DRUG

vehicle to hold xenograft

intervention

Xenograft DRUG

to maintain the socket

control

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult, systemically healthy patients with hopeless infected teeth and nonrestorable remaining structure or root.

You may not qualify if:

• Systemic or local disease/ condition that would compromise post-operative healing (e.g. Diabetics, patients who in need for systemic corticosteroids).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Interventions

Hydrogels; Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Gels; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Transplantation; Surgical Procedures, Operative

Study Officials

• socket preservation

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Eslam Mohamed Taha, master candidate

CONTACT

201120839170; eslam.taha@dentistry.cu.edu.eg

Hasan hasan abo mohamed, master candidate

CONTACT

01098923515; hasan.abomohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Comparison of xenograft with hydrogel versus xenograft alone in the socket preservation After tooth extraction: A Randomized controlled Clinical Trial

Model Details: Randomized clinical trial Parallel group study: each group of patients receives a single treatment simultaneously Two arm, superiority trial with allocation ratio 1:1 Positive controlled: both groups receiving treatment. The trial will be carried out by research in OMFS department at faculty of dentistry Cairo University

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)