Gingival Papillary CrateringNCT05953896
Efficacy of HA Gel Injection Versus Multilayer (L-PRF) in the Interdental Papilla Reconstruction
A study testing Hyaluronic acid gel and Multilayer L-PRF membranes in people with Gingival Papillary Cratering, run by Aya Elleithy at 1 site in Egypt.
Trial summary
This research aims to investigate the effectiveness of non invasive application Hyaluronic acid gel injection versus minimally invasive surgical approach using multilayer L-PRF both clinically and radiographically as a suitable treatment modality for interdental papillary deficiency. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Papillary Cratering
- What is being tested?
- Hyaluronic acid gel and Multilayer L-PRF membranes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 15 Oct 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders aged from 18-45 years.
- Systemically healthy patients.
- Patients with IDP loss class I or II of esthetic zone in upper and lower anterior and premolar teeth according to Nordland and Tarnow's classification (Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ)
- Presence of sufficient interdental alveolar bone (i.e. the vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 5 mm) that was confirmed clinically by bone sounding.
- A band of keratinized tissue should be present around the test teeth ≥ 2 mm
- Periodontal phenotype of the area to be treated is ≥ 2 mm in thickness. Surgical reconstruction of IDP is influenced by gingival tissue phenotype, outcome of papilla reconstruction is better in cases with a thick gingival unit
- Patients with good oral hygiene and caring about esthetics and concerned to go through the management of "black triangles" by interdental papillae reconstruction in esthetic zone.
Who cannot join
- Teeth with acute periapical pathosis.
- Patients with poor oral hygiene, incompliance to treatment and persistence of gingival inflammation after phase I therapy.
- Pregnant and lactating females.
- Patients having para-functional habits or local causes as, malocclusion, interdental spacing, rotation, inclination or crowding.
- Smokers, alcoholics or drug abusers.
- Vulnerable group of patients, orphans, handicapped, prisoners or mentally retarded patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Hyaluronic Acid Gel Injection Versus Multilayer Leukocyte Platelet Rich Fibrin (L-PRF) in The Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
This research aims to investigate the effectiveness of non invasive application Hyaluronic acid gel injection versus minimally invasive surgical approach using multilayer L-PRF both clinically and radiographically as a suitable treatment modality for interdental papillary deficiency.
Read the detailed description
A total of 20 patients recruited from the outpatient clinic of Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of Dentistry, Ain-Shams University and seeking treatment for black triangles for esthetic reason. Patients meeting the eligibility criteria are equally and randomly allocated in two different groups. group one Included 10 patients who received interdental papillary reconstruction using multiple layers of L-PRF. Group two Included 10 patients who received interdental papillary reconstruction using Hyaluronic acid gel injection. In the follow-up phase, patients were recalled after 3 and 6 months from intervention where clinical re-measurement of the black triangles and standardized digital clinical photographs and radiographs are done. Black triangle height and surface area was measured and other clinical parameters (Modified papillary bleeding index, Gingival index, clinical attachment level and periodontal probing depth) were assessed at baseline, 3 months and 6 months periods. patient satisfaction was evaluated using the patient satisfaction questionnaire (PSQ-18, short form) at baseline. pain and discomfort was evaluated using Numerical rating scale (NRS) at baseline, 3 months and 6 months periods. Global esthetic improvement scale (GAIS) was evaluated at 3 months and 6 months periods.
- Conditions
- Gingival Papillary Cratering
- Being tested
- Hyaluronic acid gel, Multilayer L-PRF membranes
- Keywords
- interdental papilla, multilayer L-PRF, Hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gelCombination product
Also called HA gel
For the Hyaluronic acid gel group: HA gel was injected 2-3mm apical to the coronal tip of the involved papillae and the needle was directed coronally with an angulation of 45° to the long axis of the tooth, and the bevel directed apically until papilla became blanched. The injection was given at each papilla at the following intervals baseline, one week and two weeks.
Multilayer L-PRF membranesCombination product
For the multilayer L-PRF group: A single semilunar incision is made in the buccal vestibule, apical to the muco-gingival junction in the mid interproximal area of the papilla to be treated.Tunneling of the incisions has maintained the full height and thickness of the gingiva. Multilayer L-PRF membranes were prepared according to Pinto's protocol immediately prior to the surgery and placed in the tunnel then incision was closed with simple interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid gel | Experimental | will include 10 patients undergoing non invasive reconstruction of interdental papilla using injectable Hyaluronic acid gel Receives: Combination Product: Hyaluronic acid gel |
| Multilayer L-PRF | Active comparator | will include 10 patients undergoing minimally invasive surgery for reconstruction of interdental papilla using multilayer L-PRF membranes Receives: Combination Product: Multilayer L-PRF membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gingival black triangle height
to evaluate the influence of hyaluronic acid gel injection versus multilayer L-PRF on the height of black triangle
Measured: six months
Secondary outcomes (3)
Assessment pf patient satisfaction using Patient Satisfaction Questionnaire
evaluation of patient satisfaction using patient Satisfaction questionnaire (PSQ-18, short form), patients are informed to fill and sign the questionnaire with 18 questions to evaluate their satisfaction of the recieved intervention
Measured: patients scores are evaluated at baseline immediately after the procedure
Post operative pain assessment using Numerical Pain Rating Scale
To evaluate patient's perception of postoperative pain during the treatment time using the NRS (Numeric Pain Rating Scale). The NRS is an 11-point numeric scale that ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: six months
Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)
patients satisfaction of their esthetic appearance will be rocorded using the global esthetic improvement scale with ranges (1: worsened) (2: unchanged) (3: improved) (4: much improved)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start10 Jan 2022
- Primary completion10 Jul 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Papillary CrateringStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this study is designed as a parallel randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Elleithy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Elleithy, Ain Shams University
- Investigators
- Aya Alleithy, teaching assistant, Principal investigator, Teaching assistant at Department of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, AHala Abu El-Ela, proffessor, Study director, Professor of Oral Medicine, Periodontology and Oral Diagnosis , Faculty of Dentistry-Ain Shams University & Misr International universitySusan Sarhan, lecturer, Study director, Lecturer of Oral Medicine and Periodontology and Oral diagnosis, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953896
- Sponsor's protocol ID
- FDASU-REC 012112
- Status last verified
- Jul 2023
- First submitted
- 17 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid Gel Injection Versus Multilayer Leukocyte Platelet Rich Fibrin (L-PRF) in The Interdental Papilla Reconstruction: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05953896
- Acronym / sponsor ID
- FDASU-REC 012112
- Conditions
- Gingival Papillary Cratering
- Keywords
- interdental papilla, multilayer L-PRF, Hyaluronic acid gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aya ElleithyUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 20 Jul 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.
This research aims to investigate the effectiveness of non invasive application Hyaluronic acid gel injection versus minimally invasive surgical approach using multilayer L-PRF both clinically and radiographically as a suitable treatment modality for interdental papillary deficiency.
Detailed description
A total of 20 patients recruited from the outpatient clinic of Oral Medicine, Periodontology and Oral Diagnosis department, Faculty of Dentistry, Ain-Shams University and seeking treatment for black triangles for esthetic reason. Patients meeting the eligibility criteria are equally and randomly allocated in two different groups. group one Included 10 patients who received interdental papillary reconstruction using multiple layers of L-PRF. Group two Included 10 patients who received interdental papillary reconstruction using Hyaluronic acid gel injection. In the follow-up phase, patients were recalled after 3 and 6 months from intervention where clinical re-measurement of the black triangles and standardized digital clinical photographs and radiographs are done. Black triangle height and surface area was measured and other clinical parameters (Modified papillary bleeding index, Gingival index, clinical attachment level and periodontal probing depth) were assessed at baseline, 3 months and 6 months periods. patient satisfaction was evaluated using the patient satisfaction questionnaire (PSQ-18, short form) at baseline. pain and discomfort was evaluated using Numerical rating scale (NRS) at baseline, 3 months and 6 months periods. Global esthetic improvement scale (GAIS) was evaluated at 3 months and 6 months periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- this study is designed as a parallel randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid gel | Experimental | Combination Product: Hyaluronic acid gelwill include 10 patients undergoing non invasive reconstruction of interdental papilla using injectable Hyaluronic acid gel |
| Multilayer L-PRF | Active comparator | Combination Product: Multilayer L-PRF membraneswill include 10 patients undergoing minimally invasive surgery for reconstruction of interdental papilla using multilayer L-PRF membranes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both genders aged from 18-45 years.
- Systemically healthy patients.
- Patients with IDP loss class I or II of esthetic zone in upper and lower anterior and premolar teeth according to Nordland and Tarnow's classification (Class I: Presence of the tip of the papilla between interdental contact point and the interproximal CEJ)
- Presence of sufficient interdental alveolar bone (i.e. the vertical distance from the interdental contact point to the crest of the interdental bone is ≥ 5 mm) that was confirmed clinically by bone sounding.
- A band of keratinized tissue should be present around the test teeth ≥ 2 mm
Key exclusion criteria (6 listed)
- Teeth with acute periapical pathosis.
- Patients with poor oral hygiene, incompliance to treatment and persistence of gingival inflammation after phase I therapy.
- Pregnant and lactating females.
- Patients having para-functional habits or local causes as, malocclusion, interdental spacing, rotation, inclination or crowding.
- Smokers, alcoholics or drug abusers.
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 |
|---|---|---|
| Hyaluronic acid gelAlso: HA gelFor the Hyaluronic acid gel group: HA gel was injected 2-3mm apical to the coronal tip of the involved papillae and the needle was directed coronally with an angulation of 45° to the long axis of the tooth, and the bevel directed apically until papilla became blanched. The injection was given at each papilla at the following intervals baseline, one week and two weeks. | Combination product | Hyaluronic acid gel |
| Multilayer L-PRF membranesFor the multilayer L-PRF group: A single semilunar incision is made in the buccal vestibule, apical to the muco-gingival junction in the mid interproximal area of the papilla to be treated.Tunneling of the incisions has maintained the full height and thickness of the gingiva. Multilayer L-PRF membranes were prepared according to Pinto's protocol immediately prior to the surgery and placed in the tunnel then incision was closed with simple interrupted sutures. | Combination product | Multilayer L-PRF |
Primary outcome
The gingival black triangle height
Time frame: six months
to evaluate the influence of hyaluronic acid gel injection versus multilayer L-PRF on the height of black triangle
3 secondary outcomes
Assessment pf patient satisfaction using Patient Satisfaction Questionnaire
Time frame: patients scores are evaluated at baseline immediately after the procedure
Post operative pain assessment using Numerical Pain Rating Scale
Time frame: six months
Assessment of esthetic appearance using the GAIS (global esthetic improvement scale)
Time frame: six 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 20 Jul 2023.
- Individual participant dataSharing planned: No
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.
Aya Alleithy, teaching assistant principal investigator
Teaching assistant at Department of Oral medicine, Periodontology, and Oral Diagnosis, Faculty of Dentistry, A
Hala Abu El-Ela, proffessor study director
Professor of Oral Medicine, Periodontology and Oral Diagnosis , Faculty of Dentistry-Ain Shams University & Misr International university
Susan Sarhan, lecturer study director
Lecturer of Oral Medicine and Periodontology and Oral diagnosis, Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid gel and Multilayer L-PRF membranes in people with Gingival Papillary Cratering, run by Aya Elleithy 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 7 inclusion and 6 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 20 Jul 2023. 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?
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?
The gingival black triangle height (time frame: six months). 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 20 Jul 2023.