Alveolar Ridge EnlargementNCT05781529
Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation
A study testing Alveolar ridge augmentation with injectable platelets rich fibrin, Alveolar ridge augmentation with hyaluronic acid and Alveolar ridge augmentation with xenograft in people with Alveolar Ridge Enlargement, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Enlargement
- What is being tested?
- Alveolar ridge augmentation with injectable platelets rich fibrin, Alveolar ridge augmentation with hyaluronic acid and Alveolar ridge augmentation with xenograft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesEgypt
- Study dates
- 6 Mar 2019to 31 Aug 2021
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar)
- socket type I according to Elian et al., 2007 classification
- tooth to be extracted was free from acute periapical infection or sinus tracts
- thick gingival biotype
- Systemically free according to modified Cornell medical index
Who cannot join
- smokers patients
- bruxism habits
- patients with poor oral hygiene or not willing to perform oral hygiene measures
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Doaa Adel Salah Khattab
Cairo, Abbassia, 11566
Doaa Khattab
Cairo, Abbassia, 11566
About this study
Official title: Injectable Platelets Rich Fibrin Versus Hyaluronic Acid With Bovine Derived Xenograft for Alveolar Ridge Preservation (A Randomized Controlled Clinical Trial With Histomorphometric Analysis)
Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.
Read the detailed description
The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. The assessment was done by cone beam CT preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. Histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%
- Conditions
- Alveolar Ridge Enlargement
- Being tested
- Alveolar ridge augmentation with injectable platelets rich fibrin, Alveolar ridge augmentation with hyaluronic acid, Alveolar ridge augmentation with xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge augmentation with injectable platelets rich fibrinProcedure or surgery
Also called Socket augmentation with injectable platelets rich fibrin
Injectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption
Alveolar ridge augmentation with hyaluronic acidProcedure or surgery
Also called Socket augmentation with hyaluronic acid
Hyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption
Alveolar ridge augmentation with xenograftProcedure or surgery
Also called Socket augmentation with xenograft
Xenograft is added alone as a active compatator
| Study group | Role | What they receive |
|---|---|---|
| Injectable platelets rich fibrin | Experimental | Injectable platelets rich fibrin was prepared where 10 ml of patient venous blood was centrifuged without anti-coagulants (plain plastic glass-coated) at 700 rpm speed for only 3 minutes, xenograft was mixed with I-PRF to make sticky bone, sticky bone was placed into extraction socket till the socket was fully filled up to the gingival margin Receives: Procedure: Alveolar ridge augmentation with injectable platelets rich fibrin |
| Hyaluronic acid | Experimental | Hyaluronic acid (HA) syringe containing 1 mL of cross-linked hyaluronic at a concentration of 20 mg/ml in a saline phosphate buffer solution at sterilized content was used. HA was mixed with particulate xenograft 1:10 ratio to form a putty consistency for condensation and was placed into extraction socket till the socket was fully filled up to the gingival margin Receives: Procedure: Alveolar ridge augmentation with hyaluronic acid |
| Xenograft | Active comparator | Xenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin Receives: Procedure: Alveolar ridge augmentation with xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone width
Cone beam CT (CBCT) were obtained preoperatively and 4 months postoperatively. The radiographs were analyzed using One- Viewer viewing software (iCATVision). The buccolingual width was measured into different levels. At the bone crest (A), 3mm from the bone crest (B) and 6 mm from the bone crest (C). For standardization in the sagittal slice, the axial plane was adjusted to pass through the cemento enamel junction (CEJ) of the adjacent teeth. On the axial slice, the mesiodistal dimension from the distal surface to mesial surface of the adjeceent teeth was measured. The coronal plane was adjusted to be pass through the middle of the distance in order to be perpendicular to both buccal and lingual cortices. Measurement were all performed on the coronal slices. In addition, fusion was done by superimposing preoperative and 4 months CBCT in all groups.
Measured: 4 months postoperative
Secondary outcomes (1)
histological and histomorphometric assessment
The biopsy samples were harvested and processed. All samples were serially sectioned using a microtome. Slides were stained separately with hematoxylin and eosin and observed using a light microscope. For histological evaluation and histomorphometric analysis, 20 photomicrographs from different sections taken at every 200 µm of each biopsy sample were captured at original magnification 10×, 20×, and 40× using a digital camera. The image analyzer was calibrated to automatically convert the measurement units (pixels) produced by the image analyzer program into actual micrometer units. Data from the sections of each group were averaged.
Measured: 4 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start6 Mar 2019
- Primary completion16 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge EnlargementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781529
- Sponsor's protocol ID
- 21832
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abaza G, Abdel Gaber HK, Afifi NS, Adel-Khattab D. Injectable platelet rich fibrin versus hyaluronic acid with bovine derived xenograft for alveolar ridge preservation. A randomized controlled clinical trial with histomorphometric analysis. Clin Implant Dent Relat Res. 2024 Feb;26(1):88-102. doi: 10.1111/cid.13289. Epub 2023 Oct 31.
PubMed 37905704
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Platelets Rich Fibrin Versus Hyaluronic Acid With Bovine Derived Xenograft for Alveolar Ridge Preservation (A Randomized Controlled Clinical Trial With Histomorphometric Analysis)
- ClinicalTrials.gov ID
- NCT05781529
- Acronym / sponsor ID
- 21832
- Conditions
- Alveolar Ridge Enlargement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Mar 2023 (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.
Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.
Detailed description
The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. The assessment was done by cone beam CT preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. Histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injectable platelets rich fibrin | Experimental | Procedure: Alveolar ridge augmentation with injectable platelets rich fibrinInjectable platelets rich fibrin was prepared where 10 ml of patient venous blood was centrifuged without anti-coagulants (plain plastic glass-coated) at 700 rpm speed for only 3 minutes, xenograft was mixed with I-PRF to make sticky bone, sticky bone was placed into extraction socket till the socket was fully filled up to the gingival margin |
| Hyaluronic acid | Experimental | Procedure: Alveolar ridge augmentation with hyaluronic acidHyaluronic acid (HA) syringe containing 1 mL of cross-linked hyaluronic at a concentration of 20 mg/ml in a saline phosphate buffer solution at sterilized content was used. HA was mixed with particulate xenograft 1:10 ratio to form a putty consistency for condensation and was placed into extraction socket till the socket was fully filled up to the gingival margin |
| Xenograft | Active comparator | Procedure: Alveolar ridge augmentation with xenograftXenograft was mixed with saline, placed in extraction socket till the socket is fully filled up to the gingival margin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar)
- socket type I according to Elian et al., 2007 classification
- tooth to be extracted was free from acute periapical infection or sinus tracts
- thick gingival biotype
- Systemically free according to modified Cornell medical index
Key exclusion criteria (3 listed)
- smokers patients
- bruxism habits
- patients with poor oral hygiene or not willing to perform oral hygiene measures
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 |
|---|---|---|
| Alveolar ridge augmentation with injectable platelets rich fibrinAlso: Socket augmentation with injectable platelets rich fibrinInjectable platelets rich fibrin is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption | Procedure or surgery | Injectable platelets rich fibrin |
| Alveolar ridge augmentation with hyaluronic acidAlso: Socket augmentation with hyaluronic acidHyaluronic is added to xenograft for alveolar ridge augmentation in order to preserve bone and decrease bone resorption | Procedure or surgery | Hyaluronic acid |
| Alveolar ridge augmentation with xenograftAlso: Socket augmentation with xenograftXenograft is added alone as a active compatator | Procedure or surgery | Xenograft |
Primary outcome
Radiographic bone width
Time frame: 4 months postoperative
Cone beam CT (CBCT) were obtained preoperatively and 4 months postoperatively. The radiographs were analyzed using One- Viewer viewing software (iCATVision). The buccolingual width was measured into different levels. At the bone crest (A), 3mm from the bone crest (B) and 6 mm from the bone crest (C). For standardization in the sagittal slice, the axial plane was adjusted to pass through the cemento enamel junction (CEJ) of the adjacent teeth. On the axial slice, the mesiodistal dimension from the distal surface to mesial surface of the adjeceent teeth was measured. The coronal plane was adjusted to be pass through the middle of the distance in order to be perpendicular to both buccal and lingual cortices. Measurement were all performed on the coronal slices. In addition, fusion was done by superimposing preoperative and 4 months CBCT in all groups.
1 secondary outcome
histological and histomorphometric assessment
Time frame: 4 months postoperative
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 23 Mar 2023.
- Derived from this study: PubMed 37905704Abaza G, Abdel Gaber HK, Afifi NS, Adel-Khattab D. Injectable platelet rich fibrin versus hyaluronic acid with bovine derived xenograft for alveolar ridge preservation. A randomized controlled clinical trial with histomorphometric analysis. Clin Implant Dent Relat Res. 2024 Feb;26(1):88-102. doi: 10.1111/cid.13289. Epub 2023 Oct 31.
- Individual participant dataSharing planned: Yes
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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 Alveolar ridge augmentation with injectable platelets rich fibrin, Alveolar ridge augmentation with hyaluronic acid and Alveolar ridge augmentation with xenograft in people with Alveolar Ridge Enlargement, run by Ain Shams University at 2 sites 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 5 inclusion and 3 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 23 Mar 2023. 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 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?
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?
Radiographic bone width (time frame: 4 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781529, which also lists 1 linked publication.
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 23 Mar 2023.