Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation?

March 22, 2026 updated by: Danijel Domic DMD, Medical University of Vienna

Is Cross-linked Hyaluronic Acid a Biologic Alternative for Alveolar Ridge Preservation? A Single-blind, Randomized Controlled Clinical Trial

Even after atraumatic tooth removal and/or immediate implant placement, some reduction of the alveolar ridge dimension is expected. To counteract (or limit) this reduction, alveolar ridge preservation technique (ARP) was developed. However, standard ARP techniques, such as grafting with bone substitutes, have some concerns, such as a long healing time prior to implant installation, residual graft particles, and often the need of re-grafting at implant installation. To overcome some of these limitations biologics have been discussed as an alternative approach, such as cross-linked hyaluronic acid (xHyA). However, whether the use of biologics only can achieve comparable results to the standard techniques, has yet to be answered.

The aim of the present single-blind, randomized controlled clinical trial is to test non-inferiority in terms of mid-buccal alveolar ridge height resorption 4 months after ARP between 1) control/standard treatment (i.e., grafting with bone substitutes and socket seal) and 2) test treatment (i.e., xHyA applied with a collagen sponge and socket seal) at maxillary non-molar teeth.

Forty-eight patients will be included and randomly assigned to one of the following 2 groups: 1) control group: standard ARP with deproteinized bovine bone material and covering of the socket with a free gingival graft (FGG) (n=24), 2) test group: application of xHyA soaked in a collagen sponge and covered by a FGG (n=24). The primary outcome parameter is the extent of mid-buccal alveolar ridge height resorption after 4 months, i.e., prior to implant installation, and the sample size calculation is based on a non-inferiority limit of 0.6 mm. The secondary outcome parameters are frequency of additional grafting at implant installation due to 1) a bony dehiscence or fenestration, 2) a thin buccal bone (< 1.5 mm), or 3) contour improvement, cervical alveolar ridge width, alveolar ridge volume, histomorphometric assessment of alveolar ridge healing, feasibility of implant installation, aesthetic outcome parameters, patient reported outcome measures, changes in keratinized mucosa width, soft tissue healing, and assessment of postoperative complications. Patients will be followed up to 1 year after prosthetic restoration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

(1) Patients elder than 18 years in need of (2) maxillary non-molar tooth extraction, and (3) later rehabilitation with delayed implant installation.

Exclusion Criteria:

(1) Patients with chronic diseases (e.g., uncontrolled diabetes mellitus, etc.) and/or (2) taking any medication, influencing hard or soft-tissue healing; (3) acute pain/infection or (4) presence of a fistula at the extraction site; (5) untreated periodontal disease; (6) >25% of the buccal bone plate missing after tooth extraction; (7) pregnancy; (8) history of hypersensitivity or allergy to xHyA or xenogenic bone substitute material; and (9) inability to attend the follow-up appointments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: DBBM + FGG
Deproteinized bovine bone mineral particles covered by free gingival graft
Procedure: DBBM + FGG
After tooth extraction, DBBM and FGG will be used for ARP.
Experimental: Hyaluronic acid + collagen sponge + FGG
Hyaluronic acid applied with collagen sponge and covered by free gingival graft
Procedure: Hyaluronic acid + collagen sponge + FGG
After tooth extraction, Hyaluronic acid, a collagen sponge and FGG will be used for ARP.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Extent of mid-buccal alveolar ridge height resorption
Time Frame: 4 months
The extent of mid-buccal alveolar ridge height resorption will be measured 4 months after ARP based on CBCT scans.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danijel Domic, Dr.med.dent., Department of Oral Surgery, Medical University of Vienna, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2030/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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