ClinicalTrials.gg
CompletedNCT05613075Updated Jun 5, 2025

Effect of Hyaluronic Acid, With Demineralized Tooth Graft, in Socket Preservation, vs Demineralized Tooth Graft Alone.

An interventional study of tooth extraction and socket preservation with demineralized tooth graft and tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid in Alveolar Bone Resorption, Socket Preservation and Bone Resorption, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.

Read the detailed description

The available studies provide insufficient information to assess the efficacy of the usage of ha after tooth extraction in order to induce wound healing and accelerates bone deposition and differentiation. Hence, the purpose of this clinical trial is to investigate whether there is any beneficial value of local administration of 8% ha gel formulation (gengigel ®; farmalink saglik, istanbul, turkey) on the postoperative healing phase, bone density and ridge dimensions.

In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the e-dentulous area.

Our null hypothesis that post-extraction ridges preserved with Hyaluronic acid mixed with autogenous tooth grafts will present no significant higher bone density at extraction site, nor better dimensional preservation of the ridge tooth/teeth socket(s), vertically and/or horizontally, than the normalized/standardized ridge preservation using autogenous tooth graft particulates alone, carried to serve delayed implants placement later on, at extraction sites.

02

Conditions studied

  • Alveolar Bone Resorption
  • Socket Preservation
  • Bone Resorption
  • Unrestorable Dentition

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Keywords

  • dentin graft
  • autogenous tooth graft
  • socket preservation
  • hyaluronic acid
03

In context

Bone Resorption

167 studies on the registry are indexed under Bone Resorption; 28 are open to participants now.

This study's enrollment of 30 is above the median of 24 across 146 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. 18 years old or older.
    1. Requiring alveolar preservation after tooth extraction prior to placement of dental implant.
    1. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors).
    1. Motivated patients with good enough understanding of oral health measurements and importance.
    1. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect.
    1. Patients who are healthy or have well-controlled systemic disease(s).
    1. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches.
    1. No acute infections, pus formation, socket and bony discharges.
    1. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth.
    1. Intact buccal bone of the teeth to be extracted.

Exclusion criteria

Exclusion Criteria:

    1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine).
    1. Presence of active infection or severe inflammation in the intervention zone.
    1. Relevant medical history that contraindicates implant surgery.
    1. (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories.
    1. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation.
    1. Uncontrolled diabetes (reported levels of exceeding 7%).
    1. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder.
    1. Pregnant subjects.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    tooth extraction and socket preservation with demineralized tooth graft

    patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, then covered with biodegradable Gel foaming sponge.

    Procedure: tooth extraction and socket preservation with demineralized tooth graft

  • Experimental
    tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid

    patients with immediate extraction sockets, filled and condensed with demineralized, autogenous dentinal graft particles, extracted and originated from the newly extracted tooth, mixed with Hyaluronic acid, in gel form, as a carrier, then covered with biodegradable Gel foaming sponge.

    Procedure: tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid

Interventions

  • Proceduretooth extraction and socket preservation with demineralized tooth graft

    tooth extraction and socket preservation with demineralized tooth graft

  • Proceduretooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid

    tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid

06

What researchers measure

Primary outcomes

  1. (BLRW)

    Bucco-lingual alveolar ridge width

    Time frame: 6 months

  2. (BRH)

    Height of Buccal ridge

    Time frame: 6 months

  3. (LRH).

    height of Lingual ridge

    Time frame: 6 months

Secondary outcomes

  1. Percentage of newly formed bone

    percentage of newly formed lamellar bone bundles and/or newly formed bone trabeculae

    Time frame: 6 months

  2. soft tissue healing

    percentage of complete post operative wound closure by soft tissues

    Time frame: 2 weeks

  3. residual graft

    percentage of residual bone graft particles

    Time frame: 6 months

  4. Visual analogue score (VAS)

    Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"

    Time frame: 2 weeks

07

Study locations

1 site
  • Cairo university
    Cairo, 12611, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Clinical study report

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05613075
Lead sponsor
Cairo University
Responsible party
Rahma Hesham Ahmed (dentistry post graduate master student, Implantology Department, Cairo University) — Principal investigator
First posted
Nov 14, 2022
Start date
Dec 1, 2022
Primary completion
Oct 30, 2024
Completion
Nov 29, 2024
Last update
Jun 5, 2025

Study contacts

Rahma H Mohamed Ali
principal investigator · Cairo University, Faculty of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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