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

ConditionsImmediate Implant Placement in the Esthetic ZoneNON-RESTORABLE TOOTH IN ESTHETIC ZONE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Heavy smoker (>10 cigarettes/day) (Lambert et al. 2000).

Pregnant females.

Contraindication for implant surgery.

Patients with poor oral hygiene.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate implant placement

    Procedure/Surgery

    Immediate implant placement following atraumatic tooth extraction in the esthetic zone.

  • Xenograft

    Biological/Vaccine

    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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Xenograft + Hyaluronic AcidExperimental treatment 3 interventions
Group B: Xenograft AloneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic change in labial bone thickness

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.

Time frame
Baseline and 12 months postoperatively

Secondary outcomes

1

Pink Esthetic Score (PES)

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.

Time frame
6 and 12 months postoperatively
2

Implant Stability

Implant stability will be measured using Osstell, which has a scale range from 1 to 100; the higher the ISQ, the more stability.

Time frame
6 and 12 months postoperatively
3

Crestal Bone Loss

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.

Time frame
Baseline and 12 months postoperatively
4

Amount of Bone Labial to the Implant

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.

Time frame
1 year postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: