Periodontal DiseasesNCT07088809
Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession
A study testing Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap and Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap in people with Periodontal Diseases and Gingival Recession Localized Moderate, run by Enas Elgendy at 1 site in Egypt.
Trial summary
The "Glossary of the American of Periodontology" defines gingival recession (GR) as the apical movement of the gingival margin beyond the cement-enamel junction. Therefore, root surface exposure brought on by gingival recession results in cosmetic impairment, fear of tooth loss, increased susceptibility to root… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Periodontal Diseases, Gingival Recession Localized Moderate, Nano-hydroxyapatite
- What is being tested?
- Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap and Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Sep 2025
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with good systemic health and no contraindication for periodontal surgery.
- Patients who are able to maintain good oral hygiene.
- Gingival thickness for the site selected should be ≥1mm.
- The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
Who cannot join
- Active infectious diseases (hepatitis, tuberculosis, HIV, etc….).
- Medically compromised patients.
- Patients taking medications known to cause gingival enlargement.
- Pregnant patients and smokers.
- Previous mucogingival surgery at the defect.
- Restorations or caries in the area to be treated and non vital tooth.
- Teeth which are tilted or rotated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession
The "Glossary of the American of Periodontology" defines gingival recession (GR) as the apical movement of the gingival margin beyond the cement-enamel junction. Therefore, root surface exposure brought on by gingival recession results in cosmetic impairment, fear of tooth loss, increased susceptibility to root caries, and dentin hypersensitivity. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. The medical area has been invaded by nanotechnology, and the findings are highly promising. Nanomaterials perform far better than conventional materials thanks to their superior surface, size, and quantum effects. Hydroxyapatites (HAs) are a family of materials used for bone grafting that have a high level of biocompatibility, which is partly due to their inclusion in naturally calcified tissue. The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.
Read the detailed description
The primary objective of periodontal therapy is the regeneration of periodontal tissues that have been lost owing to periodontal disease since gingival recession results in the loss of both soft and hard tissue. Periodontal regeneration, demonstrated histologically by the development of new cementum, new alveolar bone, functionally orientated periodontal ligament, and gingiva, is the rebuilding of the lost tissues. Platelet rich fibrin (PRF), which contains significant amounts of growth factors, platelets, fibrin membrane, leukocytes, and cytokines, was introduced for periodontal regeneration. The capacity of PRF to boost collagen production and fibroblast proliferation has been demonstrated, and it is widely used to repair and enhance the regeneration of both soft tissues and hard tissues following various periodontal surgical procedures. Xenografts were established in the field of periodontology to address the drawbacks of autogenous bone graft and allograft. Although these materials provide a solution to some of the aforementioned issues, the issue of immunogenicity and the transmission of disease had been frequently brought up; as a result, alloplastic materials were produced. These substances, which are artificial, inorganic, and biocompatible bone graft alternatives, offer a potential substitute for the treatment of periodontal disorders. The benefits of these materials include better accessibility, the removal of the requirement for a donor site, and the absence of any risk of disease transmission. In controlled clinical studies, hydroxyapatite (HA) and tricalcium phosphate (TCP), two alloplastic materials, significantly improved clinical outcomes at grafted locations compared to non-grafted sites. Cone beam computed tomography produces 3D images that are required in periodontics for the diagnosis of intra bony defects, furcation involvements, and destructions of the buccal and lingual bones. The objective of this study was to compare the effectiveness of nanocrystalline hydroxyapatite and tricalcium phosphate, both applied on a PRP membrane, in treating Miller's class 1 gingival recession in humans.
- Conditions
- Periodontal Diseases, Gingival Recession Localized Moderate, Nano-hydroxyapatite, Nano Tricalcium Phosphate, Platelet Rich Fibrin
- Being tested
- Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap, Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap
- Keywords
- gingival recession, nano tricalcium phosphate, nanocrystalline hydroxyapatite, platelet rich plasma
- Medical subject headings
- Periodontal Diseases, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flapProcedure or surgery
Two horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized.
Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by nanocrystale hydroxyapatite was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds.
Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flapProcedure or surgery
Two horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized.
Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by Nanocrystalline tricalcium was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds.
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap | Experimental | Ten sites with gingival recession treated with Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap. Receives: Procedure: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap |
| Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap | Experimental | Ten sites of gingival recession treated with Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap Receives: Procedure: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of root coverage (RC)
Percentage of root coverage (RC): is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
Measured: after 1, 3, 6 months post operatively
Facial bone level
Facial bone level was the distance from the apex of the tooth to most coronal point of the facial bone.
Measured: 6 months
Horizontal facial bone thickness
Horizontal facial bone thickness was the thickness of the facial bone at the middle of the root length.
Measured: after 6 months
Recession height (RH)
distance between cemento-enamel junction (CEJ) to the most apical point of the gingival margin (GM).
Measured: at 1, 3 and 6 month post surgically
Recession width (RW)
from one border of the recession to another, measured at the CEJ.
Measured: at 1, 3 and 6 month post surgically
Height of the keratinized tissue (HKT)
Height of the keratinized tissue (HKT): distance between the most apical point of the GM and the mucogingival junction (MGJ).
Measured: 1, 3 and 6 month post surgically
Secondary outcomes (6)
Bone density
Bone density: measured at the facial bone at the middle of the root length
Measured: after 6 months
Plaque index
Measured: at 1, 3 and 6 month post surgically
Gingival index (GI)
Measured: at 1, 3 and 6 month post surgically
Probing pocket depth (PPD)
Measured: at 6 months post surgically
Clinical attachment level (CAL)
Measured: at 6 months post surgically
Wound healing index (WHI)
Measured: at 14 days and 1, 3, and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Oct 2024
- Primary completion1 Jul 2025
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enas Elgendy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enas Elgendy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088809
- Sponsor's protocol ID
- Kafrelsheikh 2
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Hydroxyapetite Nanoparticles and Tricalcium Phosphate Nanoparticles Loaded on Platelet Rich Fibrin Membranes for Treatment of Gingival Recession
- ClinicalTrials.gov ID
- NCT07088809
- Acronym / sponsor ID
- Kafrelsheikh 2
- Conditions
- Periodontal Diseases, Gingival Recession Localized Moderate, Nano-hydroxyapatite, Nano Tricalcium Phosphate, Platelet Rich Fibrin
- Keywords
- gingival recession, nano tricalcium phosphate, nanocrystalline hydroxyapatite, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Enas ElgendyUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Jul 2025 (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.
The "Glossary of the American of Periodontology" defines gingival recession (GR) as the apical movement of the gingival margin beyond the cement-enamel junction. Therefore, root surface exposure brought on by gingival recession results in cosmetic impairment, fear of tooth loss, increased susceptibility to root caries, and dentin hypersensitivity. The use of free gingival grafts, sliding pedicle grafts, subepithelial connective tissue grafts, envelope or tunnelling techniques, the use of acellular dermal, connective tissue allografts, guided tissue regeneration, and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. The medical area has been invaded by nanotechnology, and the findings are highly promising. Nanomaterials perform far better than conventional materials thanks to their superior surface, size, and quantum effects. Hydroxyapatites (HAs) are a family of materials used for bone grafting that have a high level of biocompatibility, which is partly due to their inclusion in naturally calcified tissue. The aim of the present study was to compare between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.
Detailed description
The primary objective of periodontal therapy is the regeneration of periodontal tissues that have been lost owing to periodontal disease since gingival recession results in the loss of both soft and hard tissue. Periodontal regeneration, demonstrated histologically by the development of new cementum, new alveolar bone, functionally orientated periodontal ligament, and gingiva, is the rebuilding of the lost tissues. Platelet rich fibrin (PRF), which contains significant amounts of growth factors, platelets, fibrin membrane, leukocytes, and cytokines, was introduced for periodontal regeneration. The capacity of PRF to boost collagen production and fibroblast proliferation has been demonstrated, and it is widely used to repair and enhance the regeneration of both soft tissues and hard tissues following various periodontal surgical procedures. Xenografts were established in the field of periodontology to address the drawbacks of autogenous bone graft and allograft. Although these materials provide a solution to some of the aforementioned issues, the issue of immunogenicity and the transmission of disease had been frequently brought up; as a result, alloplastic materials were produced. These substances, which are artificial, inorganic, and biocompatible bone graft alternatives, offer a potential substitute for the treatment of periodontal disorders. The benefits of these materials include better accessibility, the removal of the requirement for a donor site, and the absence of any risk of disease transmission. In controlled clinical studies, hydroxyapatite (HA) and tricalcium phosphate (TCP), two alloplastic materials, significantly improved clinical outcomes at grafted locations compared to non-grafted sites. Cone beam computed tomography produces 3D images that are required in periodontics for the diagnosis of intra bony defects, furcation involvements, and destructions of the buccal and lingual bones. The objective of this study was to compare the effectiveness of nanocrystalline hydroxyapatite and tricalcium phosphate, both applied on a PRP membrane, in treating Miller's class 1 gingival recession in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap | Experimental | Procedure: Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flapTen sites with gingival recession treated with Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap. |
| Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap | Experimental | Procedure: Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flapTen sites of gingival recession treated with Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with good systemic health and no contraindication for periodontal surgery.
- Patients who are able to maintain good oral hygiene.
- Gingival thickness for the site selected should be ≥1mm.
- The height of keratinized gingiva (HKG) for the site selected should be ≥1 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
Key exclusion criteria (7 listed)
- Active infectious diseases (hepatitis, tuberculosis, HIV, etc….).
- Medically compromised patients.
- Patients taking medications known to cause gingival enlargement.
- Pregnant patients and smokers.
- Previous mucogingival surgery at the defect.
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 |
|---|---|---|
| Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flapTwo horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized. Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by nanocrystale hydroxyapatite was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds. | Procedure or surgery | Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap |
| Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flapTwo horizontal incisions were made at right angles to the adjacent interdental papillae at the CEJ level without interfering with the gingival margin of the neighbouring teeth. To mobilize the flap, two oblique vertical releasing incisions were extended beyond the mucogingival junction. A full thick¬ness trapezoidal flap was then elevated up to the mucogingival junction, and follow¬ing penetration of the periosteum, a par¬tial thickness flap was dissected further apically. The papillae mesial and distal to the recession defects were deepithelialized. Following conditioning, the root surface was rinsed with sterile saline for 1 minute. Following conditioning, the root surface the PRF membrane loaded by Nanocrystalline tricalcium was positioned to cover the recession up to CEJ. The flap was then coronally advanced to cover the membrane, and flap was closed using simple interrupted sutures. A periodontal dressing was placed over the recipient site for 10 days to protect the wounds. | Procedure or surgery | Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap |
Primary outcome
Percentage of root coverage (RC)
Time frame: after 1, 3, 6 months post operatively
Percentage of root coverage (RC): is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
Facial bone level
Time frame: 6 months
Facial bone level was the distance from the apex of the tooth to most coronal point of the facial bone.
Horizontal facial bone thickness
Time frame: after 6 months
Horizontal facial bone thickness was the thickness of the facial bone at the middle of the root length.
Recession height (RH)
Time frame: at 1, 3 and 6 month post surgically
distance between cemento-enamel junction (CEJ) to the most apical point of the gingival margin (GM).
Recession width (RW)
Time frame: at 1, 3 and 6 month post surgically
from one border of the recession to another, measured at the CEJ.
Height of the keratinized tissue (HKT)
Time frame: 1, 3 and 6 month post surgically
Height of the keratinized tissue (HKT): distance between the most apical point of the GM and the mucogingival junction (MGJ).
6 secondary outcomes
Bone density
Time frame: after 6 months
Plaque index
Time frame: at 1, 3 and 6 month post surgically
Gingival index (GI)
Time frame: at 1, 3 and 6 month post surgically
Probing pocket depth (PPD)
Time frame: at 6 months post surgically
Clinical attachment level (CAL)
Time frame: at 6 months post surgically
Wound healing index (WHI)
Time frame: at 14 days and 1, 3, and 6 months after surgery.
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 28 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap and Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap in people with Periodontal Diseases and Gingival Recession Localized Moderate, run by Enas Elgendy 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 4 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 2025. 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?
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?
Percentage of root coverage (RC) (time frame: after 1, 3, 6 months post operatively). 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 28 Jul 2025.