Alveolar Bone LossNCT07665281
Impact of Hyaluronic Acid and Bone Graft on Peri-Implant Tissue
A study testing Dental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft and Standard Dental Implants Placement only in people with Alveolar Bone Loss and Partially Edentulous Jaw, run by Al-Mustansiriyah University at 2 sites in Iraq.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Partially Edentulous Jaw, Dental Implant
- What is being tested?
- Dental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft and Standard Dental Implants Placement only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesIraq
- Study dates
- 5 Dec 2025to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old.
- Partially edentulous patients requiring dental implant placement.
- Good oral hygiene (Calibrated Gingival Bleeding Index (GBI) < 10%, O'Leary ---Plaque Index (PI) < 10%).
- Sufficient bone volume for implant placement.
Who cannot join
- Systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- Smoking > 10 cigarettes/day.
- Medications affecting bone metabolism (e.g., bisphosphonates).
- Active periodontal disease.
- Pregnant or lactating women.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites
College of Dentistry, University of Babylon
Hillah, Babylon
Private specialized dental center
Hillah, Babylon
About this study
Official title: Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"
This randomized controlled clinical trial aims to evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Healthy adult participants requiring dental implant placement will be randomly allocated into one of three equal groups (12 implants per group): Group 1 will receive dental implants combined with hyaluronic acid gel (Gengigel); Group 2 will receive dental implants combined with both hyaluronic acid and particulate bone graft; and the control group will receive dental implants alone.
Clinical and radiographic assessments will be performed using a customized measurement stent to ensure standardized evaluations at baseline, immediately postoperatively, and at 8 and 16 weeks of follow-up. The primary and secondary outcomes include alterations in ridge width, keratinized tissue width/thickness, radiographic soft tissue height, and marginal bone height. The study aims to determine whether the adjunctive use of hyaluronic acid and bone grafts enhances the quality of the peri-implant soft and hard tissue phenotype.
- Conditions
- Alveolar Bone Loss, Partially Edentulous Jaw, Dental Implant
- Being tested
- Dental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft, Standard Dental Implants Placement only
- Keywords
- dental implant, Hyaluronic acid, gingiva, bone graft, Keratinized Mucosa
- Medical subject headings
- Alveolar Bone Loss, Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implants with Hyaluronic AcidProcedure or surgery
Surgical placement of dental implants, followed by the application of hyaluronic acid gel at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
Dental Implants with Hyaluronic Acid and Particulate Bone GraftProcedure or surgery
Surgical placement of dental implants, combined with the application of hyaluronic acid gel and particulate bone graft at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype.
Standard Dental Implants Placement onlyProcedure or surgery
Standard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dental Implants + Hyaluronic Acid | Experimental | Patients receive dental implants combined with hyaluronic acid gel applied at the implant site. Receives: Procedure: Dental Implants with Hyaluronic Acid |
| Group 2: Dental Implants + Hyaluronic Acid + Bone Graft | Experimental | Patients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site. Receives: Procedure: Dental Implants with Hyaluronic Acid and Particulate Bone Graft |
| Group 3: Control Group: Dental Implants Alone | Active comparator | Patients receive standard dental implants placement alone without any adjunctive materials. Receives: Procedure: Standard Dental Implants Placement only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge Width Changes (RW)
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Measured: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.
Bone Width (BW)
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Measured: Baseline (preoperative), and 16 weeks postoperatively
Change in width of keratinized tissue (KTW)
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Measured: Baseline (preoperative), 8 weeks, and 16 weeks
Keratinized Tissue Thickness (KTT)
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Measured: Baseline (preoperative), and 16 weeks postoperatively
Radiographic Mucosal Thickness (RT)
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Measured: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks
Crestal Bone Height (BH)
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
Measured: Immediate postoperative, 8 weeks, and 16 weeks
Secondary outcomes (3)
Postoperative Pain Scores
Patients received a standardized pain assessment chart for self-evaluation over seven consecutive postoperative days. This chart featured an 11-point (0-10) Numerical Rating Scale (NRS) integrated with the Wong-Baker Faces Pain Rating Scale and supplemented with descriptive pain expressions ranging from a minimum value of 0 (representing no pain) to a maximum value of 10 (representing the worst possible pain), where higher scores indicate a worse outcome (greater pain severity).
Measured: Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively
Plaque Index (PI)
O'Leary plaque index
Measured: Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Index (GI)
Gingival Bleeding Index
Measured: Baseline (preoperative), 8 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start5 Dec 2025
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- 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
- Model description
- A randomized, controlled, parallel-group clinical trial with three arms: Group 1 (Dental Implants + Hyaluronic Acid), Group 2 (Dental Implants + Hyaluronic Acid + Particulate Bone Graft), and a Control Group (Dental Implants alone).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monya Noori Hassan, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665281
- Sponsor's protocol ID
- MUOSU/POST-202615
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hyaluronic Acid and Bone Graft on PeriImplant Tissue Phenotype."A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07665281
- Acronym / sponsor ID
- MUOSU/POST-202615
- Conditions
- Alveolar Bone Loss, Partially Edentulous Jaw, Dental Implant
- Keywords
- dental implant, Hyaluronic acid, gingiva, bone graft, Keratinized Mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 24 Jun 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 evaluate the effect of hyaluronic acid (HA) and particulate bone graft on the peri-implant tissue phenotype in patients receiving dental implants. Healthy adult participants requiring dental implant placement will be randomly allocated into one of three equal groups (12 implants per group): Group 1 will receive dental implants combined with hyaluronic acid gel (Gengigel); Group 2 will receive dental implants combined with both hyaluronic acid and particulate bone graft; and the control group will receive dental implants alone.
Clinical and radiographic assessments will be performed using a customized measurement stent to ensure standardized evaluations at baseline, immediately postoperatively, and at 8 and 16 weeks of follow-up. The primary and secondary outcomes include alterations in ridge width, keratinized tissue width/thickness, radiographic soft tissue height, and marginal bone height. The study aims to determine whether the adjunctive use of hyaluronic acid and bone grafts enhances the quality of the peri-implant soft and hard tissue phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, controlled, parallel-group clinical trial with three arms: Group 1 (Dental Implants + Hyaluronic Acid), Group 2 (Dental Implants + Hyaluronic Acid + Particulate Bone Graft), and a Control Group (Dental Implants alone).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Dental Implants + Hyaluronic Acid | Experimental | Procedure: Dental Implants with Hyaluronic AcidPatients receive dental implants combined with hyaluronic acid gel applied at the implant site. |
| Group 2: Dental Implants + Hyaluronic Acid + Bone Graft | Experimental | Procedure: Dental Implants with Hyaluronic Acid and Particulate Bone GraftPatients receive dental implants combined with hyaluronic acid gel and particulate bone graft applied at the implant site. |
| Group 3: Control Group: Dental Implants Alone | Active comparator | Procedure: Standard Dental Implants Placement onlyPatients receive standard dental implants placement alone without any adjunctive materials. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years old.
- Partially edentulous patients requiring dental implant placement.
- Good oral hygiene (Calibrated Gingival Bleeding Index (GBI) < 10%, O'Leary ---Plaque Index (PI) < 10%).
- Sufficient bone volume for implant placement.
Key exclusion criteria (5 listed)
- Systemic conditions affecting bone healing (e.g., uncontrolled diabetes).
- Smoking > 10 cigarettes/day.
- Medications affecting bone metabolism (e.g., bisphosphonates).
- Active periodontal disease.
- Pregnant or lactating women.
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 |
|---|---|---|
| Dental Implants with Hyaluronic AcidSurgical placement of dental implants, followed by the application of hyaluronic acid gel at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype. | Procedure or surgery | Group 1: Dental Implants + Hyaluronic Acid |
| Dental Implants with Hyaluronic Acid and Particulate Bone GraftSurgical placement of dental implants, combined with the application of hyaluronic acid gel and particulate bone graft at the implant site, was performed to evaluate its impact on peri-implant tissue phenotype. | Procedure or surgery | Group 2: Dental Implants + Hyaluronic Acid + Bone Graft |
| Standard Dental Implants Placement onlyStandard surgical placement of dental implants following conventional clinical protocols without the application of any adjunctive materials. | Procedure or surgery | Group 3: Control Group: Dental Implants Alone |
Primary outcome
Ridge Width Changes (RW)
Time frame: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.
The changes in Ridge Width is measured at the reference points using a digital vernier caliper.
Bone Width (BW)
Time frame: Baseline (preoperative), and 16 weeks postoperatively
Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width.
Change in width of keratinized tissue (KTW)
Time frame: Baseline (preoperative), 8 weeks, and 16 weeks
Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper.
Keratinized Tissue Thickness (KTT)
Time frame: Baseline (preoperative), and 16 weeks postoperatively
Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper.
Radiographic Mucosal Thickness (RT)
Time frame: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks
Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant.
Crestal Bone Height (BH)
Time frame: Immediate postoperative, 8 weeks, and 16 weeks
Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone.
3 secondary outcomes
Postoperative Pain Scores
Time frame: Three times daily (morning, afternoon, and evening) for the first 7 days postoperatively
Plaque Index (PI)
Time frame: Baseline (preoperative), 8 weeks, and 16 weeks
Gingival Index (GI)
Time frame: Baseline (preoperative), 8 weeks, and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implants with Hyaluronic Acid, Dental Implants with Hyaluronic Acid and Particulate Bone Graft and Standard Dental Implants Placement only in people with Alveolar Bone Loss and Partially Edentulous Jaw, run by Al-Mustansiriyah University at 2 sites in Iraq.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ridge Width Changes (RW) (time frame: Baseline (preoperative), immediate postoperative, 8 weeks, and 16 weeks.). The study lists 6 primary outcomes in all. 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 Jul 2026.