Immediate Implant Placement in the Esthetic ZoneNCT07862686
Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement
A study testing Immediate implant placement, Xenograft and Hyaluronic Acid (0.2%) in people with Immediate Implant Placement in the Esthetic Zone and NON-RESTORABLE TOOTH IN ESTHETIC ZONE, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immediate Implant Placement in the Esthetic Zone, NON-RESTORABLE TOOTH IN ESTHETIC ZONE
- What is being tested?
- Immediate implant placement, Xenograft and Hyaluronic Acid (0.2%)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- Good oral health.
- Willingness to sign the informed consent form.
- Adult patients more than 18 years of age.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Mohamed Hatem Fouad, BDS, +201207389161, mohamed.sobhi@dentistry.cu.edu.eg
About this study
Official title: 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
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.
- Being tested
- Immediate implant placement, Xenograft, Hyaluronic Acid (0.2%)
- Keywords
- Bone Grafting, Alveolar Ridge, Jumping Gap, Esthetic Zone, Xenograft, Hyaluronic Acid, Immediate Implant Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placementProcedure or surgery
Immediate implant placement following atraumatic tooth extraction in the esthetic zone.
XenograftBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft + Hyaluronic Acid | Experimental | Immediate implant placement with the jumping gap filled with xenograft combined with hyaluronic acid Receives: Procedure: Immediate implant placement; Biological: Xenograft; Drug: Hyaluronic Acid (0.2%) |
| Xenograft Alone | Active comparator | Immediate implant placement with the jumping gap filled with xenograft alone. Receives: Procedure: Immediate implant placement; Biological: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months postoperatively
Secondary outcomes (4)
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.
Measured: 6 and 12 months postoperatively
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.
Measured: 6 and 12 months postoperatively
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.
Measured: Baseline and 12 months postoperatively
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.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant Placement in the Esthetic ZoneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hatem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862686
- Sponsor's protocol ID
- PER 6_3_1
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07862686
- Acronym / sponsor ID
- PER 6_3_1
- Keywords
- Bone Grafting, Alveolar Ridge, Jumping Gap, Esthetic Zone, Xenograft, Hyaluronic Acid, Immediate Implant Placement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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: XenograftImmediate implant placement with the jumping gap filled with xenograft alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate implant placementImmediate implant placement following atraumatic tooth extraction in the esthetic zone. | Procedure or surgery | Xenograft + Hyaluronic Acid, Xenograft Alone |
| XenograftXenograft bone graft material used to fill the jumping gap around the immediately placed implant | Biological | Xenograft + Hyaluronic Acid, Xenograft Alone |
| Hyaluronic Acid (0.2%)Hyaluronic acid gel (0.2%) combined with xenograft for filling the jumping gap around the immediately placed implant. | Drug | Xenograft + Hyaluronic Acid |
Primary outcome
Radiographic change in labial bone thickness
Time frame: 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.
4 secondary outcomes
Pink Esthetic Score (PES)
Time frame: 6 and 12 months postoperatively
Implant Stability
Time frame: 6 and 12 months postoperatively
Crestal Bone Loss
Time frame: Baseline and 12 months postoperatively
Amount of Bone Labial to the Implant
Time frame: 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant placement, Xenograft and Hyaluronic Acid (0.2%) in people with Immediate Implant Placement in the Esthetic Zone and NON-RESTORABLE TOOTH IN ESTHETIC ZONE, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic change in labial bone thickness (time frame: Baseline and 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.