PeriodontitisNCT06016894
Hydroxyapetite Nanoparticles, Tricalcium Phosphate Nanoparticles, and PRF for Treatment of Gingival Recession
A study testing coronally advanced flap, Nanocrystalline hydroxyapatite loaded in PRF and Nanocrystalline tricalcium phosphate loaded in PRF in people with Periodontitis, run by October 6 University.
Trial summary
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 more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- coronally advanced flap, Nanocrystalline hydroxyapatite loaded in PRF and Nanocrystalline tricalcium phosphate loaded in PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2000to 22 Apr 2023
- 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
- 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.
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 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
gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel junction. 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, Platelet rich fibrin (PRF), and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP) is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is one of the most popular and effective artificial bone substitutes. It is osteoinductive as well as osteoconductive. These characteristics enable full bone defects regeneration together with its cell-mediated resorption. In this study, we compared between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.
- Conditions
- Periodontitis
- Being tested
- coronally advanced flap, Nanocrystalline hydroxyapatite loaded in PRF, Nanocrystalline tricalcium phosphate loaded in PRF
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronally advanced flapProcedure or surgery
coronally advanced flap operation
Nanocrystalline hydroxyapatite loaded in PRFOther
Nanocrystalline hydroxyapatite loaded in PRF
Nanocrystalline tricalcium phosphate loaded in PRFOther
Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline hydroxyapatite | Active comparator | Nanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap Receives: Procedure: coronally advanced flap; Other: Nanocrystalline hydroxyapatite loaded in PRF |
| Nanocrystalline tricalcium phosphate (NcTCP) | Active comparator | Nanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap Receives: Procedure: coronally advanced flap; Other: Nanocrystalline tricalcium phosphate loaded in PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recession height
measurement recession height
Measured: 6 months
Recession width
measurement of Recession width
Measured: 6 months
Height of the keratinized tissue
measurement of Height of the keratinized tissue
Measured: 6 months
Percentage of root coverage
It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
Measured: 6 months
Radiographic assessment
measurement of buccal bone gain
Measured: 6 months
Secondary outcomes (2)
Probing pocket depth
measurement of Probing pocket depth
Measured: 6 months
Clinical attachment level
measurement of Clinical attachment level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Sep 2000
- Primary completion20 Sep 2022
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016894
- Sponsor's protocol ID
- khafrelsheikh university
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- 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 30 Aug 2023. 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
- NCT06016894
- Acronym / sponsor ID
- khafrelsheikh university
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Sep 2000 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 30 Aug 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.
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
gingival recession (GR) is apical movement of the gingival margin beyond the cement-enamel junction. 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, Platelet rich fibrin (PRF), and coronally advanced flap (CAF) are the surgical methods that have been developed to treat gingival recession. For treatments of intrabony defects, a synthetic nanocrystalline hydroxyapatite (NcHA) bone graft has been introduced. Osteoconductivity, bioresorbability, and close contact are benefits of NcHA material. Critical size defects showed quick healing when the NcHA was utilised as a bone graft alternative. NcHA binds to bone and increases osteoblast activity to promote bone regeneration. A promising bone replacement material, tricalcium phosphate (TCP) is known for its strong bioactivity and resorbable qualities. Tricalcium phosphate (TCP) is one of the most popular and effective artificial bone substitutes. It is osteoinductive as well as osteoconductive. These characteristics enable full bone defects regeneration together with its cell-mediated resorption. In this study, we compared between nanocrystalline hydroxyapatite and tricalcium phosphate carried on PRP membrane in treatment of Miller's class 1 gingival recession in human.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline hydroxyapatite | Active comparator | Procedure: coronally advanced flap, Other: Nanocrystalline hydroxyapatite loaded in PRFNanocrystalline hydroxyapatite loaded in PRF+ coronally advanced flap |
| Nanocrystalline tricalcium phosphate (NcTCP) | Active comparator | Procedure: coronally advanced flap, Other: Nanocrystalline tricalcium phosphate loaded in PRFNanocrystalline tricalcium phosphate (NcTCP) loaded in PRF+ coronally advanced flap |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| coronally advanced flapcoronally advanced flap operation | Procedure or surgery | Nanocrystalline hydroxyapatite, Nanocrystalline tricalcium phosphate (NcTCP) |
| Nanocrystalline hydroxyapatite loaded in PRFNanocrystalline hydroxyapatite loaded in PRF | Other | Nanocrystalline hydroxyapatite |
| Nanocrystalline tricalcium phosphate loaded in PRFNanocrystalline tricalcium phosphate (NcTCP) loaded in PRF | Other | Nanocrystalline tricalcium phosphate (NcTCP) |
Primary outcome
Recession height
Time frame: 6 months
measurement recession height
Recession width
Time frame: 6 months
measurement of Recession width
Height of the keratinized tissue
Time frame: 6 months
measurement of Height of the keratinized tissue
Percentage of root coverage
Time frame: 6 months
It is calculated after 1, 3, 6 months as [RH preoperative - RH postoperative]/RH preoperative) x 100%.
Radiographic assessment
Time frame: 6 months
measurement of buccal bone gain
2 secondary outcomes
Probing pocket depth
Time frame: 6 months
Clinical attachment level
Time frame: 6 months
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 30 Aug 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing coronally advanced flap, Nanocrystalline hydroxyapatite loaded in PRF and Nanocrystalline tricalcium phosphate loaded in PRF in people with Periodontitis, run by October 6 University.
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: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Recession height (time frame: 6 months). The study lists 5 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 30 Aug 2023.