Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement

NCT07862686 — Not applicable, Not yet recruiting, 12 participants, Cairo University

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Clinical and Radiographic Evaluation of Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement in the Esthetic Zone: A Randomized Clinical Trial

Registry	NCT07862686
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	12 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Immediate Implant Placement in the Esthetic Zone, NON-RESTORABLE TOOTH IN ESTHETIC ZONE
Interventions	Immediate implant placement, Xenograft, Hyaluronic Acid (0.2%) (Procedure, biological, drug)
Dates	start 2026-09-01 (estimated), primary completion 2027-07-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-10-07, last updated 2026-10-07
Locations	1 site in Egypt

-Summary

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of immediate implant placement using xenograft combined with hyaluronic acid versus xenograft alone in the esthetic zone. Patients requiring extraction of a non-restorable tooth followed by immediate implant placement will be randomly allocated to two groups. In the intervention group, the jumping gap between the implant and facial bone wall will be grafted with xenograft combined with hyaluronic acid, while in the control group, xenograft alone will be used. The primary outcome is the radiographic change in the labio-palatal ridge width. Secondary outcomes include pink esthetic score, implant stability, crestal bone loss, and the amount of bone labial to the implant. Patients will be followed for up to 12 months postoperatively.

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+Arms and interventions

Arm	Type	Interventions	Description
Xenograft + Hyaluronic Acid	Experimental	Procedure: Immediate implant placement; Biological: Xenograft; Drug: Hyaluronic Acid (0.2%)	Immediate implant placement with the jumping gap filled with xenograft combined with hyaluronic acid
Xenograft Alone	Active comparator	Procedure: Immediate implant placement; Biological: Xenograft	Immediate implant placement with the jumping gap filled with xenograft alone.

Immediate implant placement (Procedure): Immediate implant placement following atraumatic tooth extraction in the esthetic zone.
Xenograft (Biological): Xenograft bone graft material used to fill the jumping gap around the immediately placed implant
Hyaluronic Acid (0.2%) (Drug): Hyaluronic acid gel (0.2%) combined with xenograft for filling the jumping gap around the immediately placed implant.

+Outcome measures

Primary outcomes

Radiographic change in labial bone thickness [Baseline and 12 months postoperatively]: Radiographic change in labio-palatal ridge width at 0, 2 and 5 mm from the crest of bone labial to the implant, assessed using CBCT.

Secondary outcomes

Pink Esthetic Score (PES) [6 and 12 months postoperatively]: Esthetic evaluation using the Pink Esthetic Score (PES). Seven variables are evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. A 0-1-2 scoring system is used, with 0 being the lowest and 2 being the highest value for each parameter. The maximum achievable PES is 14.
Implant Stability [6 and 12 months postoperatively]: Implant stability will be measured using Osstell, which has a scale range from 1 to 100; the higher the ISQ, the more stability.
Crestal Bone Loss [Baseline and 12 months postoperatively]: Crestal bone loss will be evaluated using CBCT at two time points. Vertical crestal bone-level changes will be measured and standardized to assess bone-level changes around the implant.
Amount of Bone Labial to the Implant [1 year postoperatively]: The amount of bone formed labial to the implant will be measured at three levels below the labial bone crest: 0 mm, 2 mm and 5 mm, using CBCT.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Non-restorable tooth in the esthetic zone.
* Thin labial plate of bone (≤1 mm) maintained after tooth extraction.
* Teeth with no acute inflammation.
* Thick soft tissue biotype.
* Patients free from any systemic condition that may affect the healing.
* Availability of bone apical and palatal to the socket to provide primary stability for the immediate implant (Morton et al. 2014).
* Good oral health.
* Willingness to sign the informed consent form.
* Adult patients more than 18 years of age.

Exclusion Criteria:

* Heavy smoker (>10 cigarettes/day) (Lambert et al. 2000).
* Pregnant females.
* Contraindication for implant surgery.
* Patients with poor oral hygiene.
* Acute inflammation in the site of implantation and adjacent tissue.
* A history of radiotherapy in the head or neck region.
* Patients with systemic disease like uncontrolled diabetes mellitus, coagulation disorders, alcohol or drug abuse not suitable for implantation (Wu et al. 2019).

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Cairo University	Cairo	Egypt