Sticky Bone vs Xenograft With Cross-linked Hyaluronic Acid in Socket Preservation

NCT06983015 | Not Yet Recruiting

• 1 other identifier: socket preservation
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation.

Conditions

Socket Preservation

Keywords

sticky bone; xenograft with cross-linked hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points

  A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points (8): * Apico-coronally: Coronally the most crestal bone peak will be detected mesially and distally; apically, an artificial line was drawn 1.5 mm below the most apical point of the root tip across the apical base of the socket. * Mesio-distally: limited by an artificial line at 1.5 mm distance of the most mesial and distal surface of adjacent tooth or implant. * Bucco-lingually: limited to the mostly detectable bone width extension.

  This measurement will be obtained at immediate postoperative and 6-months postoperative.

Secondary Outcomes (3)

• Bone density

  This measurement will be obtained at immediate postoperative and 6-months postoperative.

• Postoperative Pain

  at the following intervals: 1, 3, 7th day postoperative.

• Bone volume

  This measurement will be obtained at immediate postoperative and 6-months postoperative.

Study Arms (2)

sticky bone

EXPERIMENTAL

patients in this group will undergo tooth extraction and immediate augmentation using sticky bone

Procedure: sticky bone

xenograft mixed with cross-linked hyaluronic acid

ACTIVE COMPARATOR

patients in this group will undergo tooth extraction and immediate augmentation using xenograft mixed with cross-linked hyaluronic acid

Procedure: xenograft mixed with cross-linked hyaluronic acid

Interventions

sticky bone PROCEDURE

extraction socket will be augmented using a sticky bone.

sticky bone

xenograft mixed with cross-linked hyaluronic acid PROCEDURE

Socket will be augmented with a mixture of xenograft and cross linked hyaluronic acid.

xenograft mixed with cross-linked hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old.
• Patient with hopeless maxillary anteriors and premolar with cl ii socket that needs extraction and delayed implant placement.

You may not qualify if:

• Acute abscesses or active infections localized in the proximity of the surgical field.
• Presence of heavy metallic artefacts that can distort CBCT scans
• Bad oral hygiene and non-compliance.
• Systemic diseases interfering with bone healing.
• Active and progressive periodontal disease
• Smoking, alcoholism and drug abuse
• Pregnant and lactating women

Sponsors & Collaborators

• Fayoum University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: oral and maxillofacial surgery master candidate

Model Details: This prospective randomized (1:1) blinded clinical trial used an unstratified random block design (block sizes2, 4, and 6) to ensure balance in the number of patients assigned to each group. Informed consent for sharing clinical data and images for scientific purposes will be collected from all patients prior to commencement of the study, which was performed in accordance with the Declaration of Helsinki. The patients will be randomly assigned to one of the two groups according to the graft material: group I (Sticky bone) and group II (cross linked hyaluronic acid mixed with xenograft) where each patient will received either sticky bone or cross linked hyaluronic acid mixed with xenograft in the extraction socket according to the treatment group by the same operator. The graft material for extraction socket will be the primary predictor variable.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05