Interdental Papillae ReconstructionNCT06889311
A Modern, Non-surgical Method for Treating Papillary Deficiencies is the Use of Hyaluronic Acid, Which Have Demonstrated Encouraging Outcome. Subperiosteal Hyaluronic Acid Injection Overlay Technique with the Idea of Merging Hyaluronic Acid Injection with Surgical Intervention to Reconstruct Idp
A study testing Subperiosteal hyaluronic acid injection overlay technique and Tunneling with connective tissue graft. in people with Interdental Papillae Reconstruction and Hyaluronic Acid, run by Cairo University.
Trial summary
The interdental papilla is a crucial part of an esthetic smile, its loss results in gingival black triangles giving unpleasant appearance which directly affect patient self-esteem (Lee et al. 2016). The presence of interdental papilla is of great concern for the clinician and the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interdental Papillae Reconstruction, Hyaluronic Acid
- What is being tested?
- Subperiosteal hyaluronic acid injection overlay technique and Tunneling with connective tissue graft.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients aged over 18 years. 2. Class I papillary recession according to the Nordland and Tarnow classification system. (Nordland and Tarnow 1998) 3. Patients free from any systemic conditions that may affect healing. (Hamadeh et al. 2024).
- 4. The distance between the contact point to alveolar crest between 5 to 7 mm. 5. Presence of the adjacent teeth. 6. Compliant patients with good oral hygiene.
Who cannot join
- 1. Smokers. 2. Pregnant females. 3. Patients with active periodontal disease. 4. Patients who has spacing or crowding between the teeth to be treated. 5. Abnormal tooth shape or adjacent teeth with caries. 6. Presence of proximal restoration or orthodontic appliances or fixed prosthesis.
- 7. Patients with poor oral hygiene according to plaque index score of 2.0 to 3.0 evaluated according to the criteria of Silness and Loe.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Subperiosteal Hyaluronic Acid Injection Overlay Technique Compared to Tunneling with Connective Tissue Graft in Management of Interdental Papillary Defects: a Randomized Clinical Trial
The interdental papilla is a crucial part of an esthetic smile, its loss results in gingival black triangles giving unpleasant appearance which directly affect patient self-esteem (Lee et al. 2016). The presence of interdental papilla is of great concern for the clinician and the patient. Gingival black triangles are considered to be the most disliked esthetic issue. As well open embrasures can cause food impaction and phonetic problems (Prato et al. 2004).
The treatment of black triangles is challenging in modern dentistry. The treatment options are surgical and non-surgical. Surgical treatments are invasive and do not always give a predictable result due to limited blood supply of the papilla (Mansouri 2013).
Read more
However, no technique has been set up as a gold standard treatment for gingival black triangles, although, connective tissue graft surgical techniques are the most common used approaches for treatment of black triangles (RahimiRad 2018).
A modern, non-surgical method for treating papillary deficiencies is the use of hyaluronic acid, which have demonstrated encouraging outcome (Ni et al. 2021). Subperiosteal hyaluronic acid injection overlay technique was proposed by Spano et al, (2020) with the idea of merging hyaluronic acid injection with simple surgical intervention to reconstruct the lost interdental papilla. As far as we know, there is no present studies comparing hyaluronic acid overlay technique with connective tissue graft in treatment of interdental papilla deficiencies.
Read the detailed description
The interdental papilla is an important anatomical part of the gingiva. It can reduce by time or by different etiological factors as crown shape or presence of periodontal diseases which results in presence of highly unaesthetic black triangles which frequently cause patients complaints in both appearance and function (Patel et al. 2024). The interdental papilla is a part of the gingiva that fills the embrasure space between the contact point of the adjacent teeth. It is supported by the underlying alveolar bone and laterally by the presence of the teeth. It is composed of masticatory mucosa and composed of dense connective tissue covered with oral epithelium (Prato et al. 2004).
Tarnow et al (1992) investigated a relationship between the distance of interdental bone level and contact point and the presence or absence of the interdental papilla. They found that a distance of 3-4 mm, an intact interdental papilla was present. While, when the distance increased to 6 mm and above, there was partial or complete absence of the interdental papilla and the absence of the papilla increased with every millimeter. The interdental papilla can be lost due to interproximal bone loss due to periodontitis or may be iatrogenic damage such as over-countered restorations and crown preparations. In addition, tooth-related factors can cause loss of interdental papilla as loss of contact point, tooth malposition, abnormal tooth shape, triangular-shaped crowns, diastamas, divergent roots and over-eruption of a tooth (Kurth and Kokich 2001).
Nordland and Tarnow (1998) proposed a classification for the loss of interdental papilla which is based on three references: the contact point, buccal apical extent of the cemento-enamel junction (CEJ) and the interproximal CEJ. The classification follows: Normal: when the interdental papilla fills the embrasure space to contact point, Class I: the tip of the papilla lies between the interdental contact point and the most coronal extent of CEJ, Class II: the tip of the papilla lies at or apical to the interdental CEJ but coronal to facial CEJ and Class III: when the tip of the papilla lies at a level apical to the facial CEJ.
Different surgical and non-surgical techniques have been proposed for treatment of interdental papillary deficiency based on the etiological factor with some of degree of success. Among these treatments are the correction of traumatic oral hygiene practices, papilla enhancement with either autologous fibroblast injection or hyaluronic acid and orthodontic therapy (Singh et al. 2013). Among surgical approaches to reconstruct the lost papilla are connective tissue graft base surgical techniques. The surgical treatment of deficient papilla with the connective tissue graft remained the most used approach however, it requires a good vascular supply in the interdental papilla and requires a second surgical site (Gobbato et al. 2016).
Hyaluronic acid injection in the deficient interdental papilla has shown promising results (Fakhari and Berkland 2013; Lee et al. 2016; Ni et al. 2021). Hyaluronic acid is a polysaccharide present in the body tissues. Under physiologic conditions it binds to water and swells in a gel form, resulting in smoother tissue counters. The role of hyaluronic acid in augmentation is by inducing water absorption of gingival fibroblast proliferation. When hyaluronic acid is incorporated into an aqueous solution, hydrogen bonding occurs between adjacent carboxyl and N-acetyl groups; this feature allows hyaluronic acid to maintain conformational stiffness to retain water (Bertl et al. 2017). Also, it may affection collagen remodeling by increasing the production of procollagens and matrix metalloproteinase-1 secretion by fibroblast (Singh et al. 2013). Hyaluronic acid showed a satisfactory result in regeneration of lost interdental papilla at 6 and 12 months (Ficho et al. 2021).
- Being tested
- Subperiosteal hyaluronic acid injection overlay technique, Tunneling with connective tissue graft.
- Keywords
- Hyaluronic acid, Interdental papilla, Black triangle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subperiosteal hyaluronic acid injection overlay techniqueProcedure or surgery
using subperiosteal hyaluronic acid injection overlay technique showed promising results in treating lost interdental papilla which needs further assessment to its clinical effectiveness
Tunneling with connective tissue graft.Procedure or surgery
Connective tissue graft base techniques have been for years the most predictable approach for treatment of interdental papillary defects. CTG can as a biological filler which enhances flap stability and wound strength. CTG also can promote coagulation cascade and protects the maturating fibrin clot (Tavelli et al. 2019). Moreover, CTG results in significant increase in gingival tissue thickness which positively improve tissue fill and soft tissue volume creeping which influence esthetic outcomes following periodontal regeneration
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Procedure: Subperiosteal hyaluronic acid injection overlay technique |
| Group B | Active comparator | Not described Receives: Procedure: Tunneling with connective tissue graft. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in papilla height
Clinical changes in papilla will be recorded by measuring papilla height at the distance between the tip of the papilla and the incisal edge of the adjacent tooth using UNC periodontal probe .
Measured: Changes will be recorded at 3, 6 and 12 months
Secondary outcomes (7)
Percentage of changes in papilla height
the percentage of change in papilla height will be calculated with a reference to baseline following equation PH baseline- PH timepoint / PH baseline
Measured: 3, 6 and 12 months
Papilla presence index
The papilla presence index will be recorded at baseline, 3, 6 and 12 months follow up. The scores will be measured as follows: PPI 1: When the papilla is completely present and coronally extends to the contact point to completely fill the embrasure. It is at same level of adjacent papilla PPI 2: Papilla is no longer completely present and lies apical to the contact point and not at the same level as the adjacent papillae, but the interproximal CEJ is still not visible. PPI 3: Papilla is moved more apical and the interproximal CEJ becomes visible. PPI 4: Papilla lies apical to both the interproximal CEJ and buccal CEJ.
Measured: 3, 6 and 12 months
Clinical attachment loss
A UNC probe will used to estimate this measurement. The probe will be inserted in the gingival sulcus and CAL will be measured as the distance from CEJ to the bottom of the sulcus
Measured: 3, 6 and 12 months
Gingival thickness
Gingival thickness will be measured 2 mm apical to the gingival margin with an aesthetic needle with a silicon stopper. The needle will be inserted perpendicular to the mucosal surface, through soft tissue with light pressure until resistance will be felt once the tip of needle is in contact with bone. The silicone stopper will be moved towards until it reaches the external surface of mucosal tissues. The penetration depth will be measured using UNC graduated probe by measuring the distance from the tip of the needle to silicone stopper
Measured: 3, 6 and 12 months
Post-operative pain
Visual analogue scale (VAS) will be used to record post-operative pain. The pain will be measured as follows from 0, no pain to 10, maximum pain and will be measured at day 1,3 and 10 days post-surgical.
Measured: 1,3 and 10 days post-surgical.
Patients' esthetic satisfaction
VAS will be used to record patients' esthetic satisfaction at six months. The satisfaction will be measured as follows (equal, better or worse than pre-surgery). Questionnaire will be taken for esthetic satisfaction, tooth brushing ability and dental hypersensitivity.
Measured: 12 months
The need for analgesics
The pain will be measured indirectly by the total number of analgesic tablets that will be consumed by the patients after surgery by 10 days.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdental Papillae ReconstructionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Amagad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889311
- Sponsor's protocol ID
- CEBD-CU-2024-12-16
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Subperiosteal Hyaluronic Acid Injection Overlay Technique Compared to Tunneling with Connective Tissue Graft in Management of Interdental Papillary Defects: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06889311
- Acronym / sponsor ID
- CEBD-CU-2024-12-16
- Keywords
- Hyaluronic acid, Interdental papilla, Black triangle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Mar 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 interdental papilla is a crucial part of an esthetic smile, its loss results in gingival black triangles giving unpleasant appearance which directly affect patient self-esteem (Lee et al. 2016). The presence of interdental papilla is of great concern for the clinician and the patient. Gingival black triangles are considered to be the most disliked esthetic issue. As well open embrasures can cause food impaction and phonetic problems (Prato et al. 2004).
The treatment of black triangles is challenging in modern dentistry. The treatment options are surgical and non-surgical. Surgical treatments are invasive and do not always give a predictable result due to limited blood supply of the papilla (Mansouri 2013).
However, no technique has been set up as a gold standard treatment for gingival black triangles, although, connective tissue graft surgical techniques are the most common used approaches for treatment of black triangles (RahimiRad 2018).
A modern, non-surgical method for treating papillary deficiencies is the use of hyaluronic acid, which have demonstrated encouraging outcome (Ni et al. 2021). Subperiosteal hyaluronic acid injection overlay technique was proposed by Spano et al, (2020) with the idea of merging hyaluronic acid injection with simple surgical intervention to reconstruct the lost interdental papilla. As far as we know, there is no present studies comparing hyaluronic acid overlay technique with connective tissue graft in treatment of interdental papilla deficiencies.
Detailed description
The interdental papilla is an important anatomical part of the gingiva. It can reduce by time or by different etiological factors as crown shape or presence of periodontal diseases which results in presence of highly unaesthetic black triangles which frequently cause patients complaints in both appearance and function (Patel et al. 2024). The interdental papilla is a part of the gingiva that fills the embrasure space between the contact point of the adjacent teeth. It is supported by the underlying alveolar bone and laterally by the presence of the teeth. It is composed of masticatory mucosa and composed of dense connective tissue covered with oral epithelium (Prato et al. 2004).
Tarnow et al (1992) investigated a relationship between the distance of interdental bone level and contact point and the presence or absence of the interdental papilla. They found that a distance of 3-4 mm, an intact interdental papilla was present. While, when the distance increased to 6 mm and above, there was partial or complete absence of the interdental papilla and the absence of the papilla increased with every millimeter. The interdental papilla can be lost due to interproximal bone loss due to periodontitis or may be iatrogenic damage such as over-countered restorations and crown preparations. In addition, tooth-related factors can cause loss of interdental papilla as loss of contact point, tooth malposition, abnormal tooth shape, triangular-shaped crowns, diastamas, divergent roots and over-eruption of a tooth (Kurth and Kokich 2001).
Nordland and Tarnow (1998) proposed a classification for the loss of interdental papilla which is based on three references: the contact point, buccal apical extent of the cemento-enamel junction (CEJ) and the interproximal CEJ. The classification follows: Normal: when the interdental papilla fills the embrasure space to contact point, Class I: the tip of the papilla lies between the interdental contact point and the most coronal extent of CEJ, Class II: the tip of the papilla lies at or apical to the interdental CEJ but coronal to facial CEJ and Class III: when the tip of the papilla lies at a level apical to the facial CEJ.
Different surgical and non-surgical techniques have been proposed for treatment of interdental papillary deficiency based on the etiological factor with some of degree of success. Among these treatments are the correction of traumatic oral hygiene practices, papilla enhancement with either autologous fibroblast injection or hyaluronic acid and orthodontic therapy (Singh et al. 2013). Among surgical approaches to reconstruct the lost papilla are connective tissue graft base surgical techniques. The surgical treatment of deficient papilla with the connective tissue graft remained the most used approach however, it requires a good vascular supply in the interdental papilla and requires a second surgical site (Gobbato et al. 2016).
Hyaluronic acid injection in the deficient interdental papilla has shown promising results (Fakhari and Berkland 2013; Lee et al. 2016; Ni et al. 2021). Hyaluronic acid is a polysaccharide present in the body tissues. Under physiologic conditions it binds to water and swells in a gel form, resulting in smoother tissue counters. The role of hyaluronic acid in augmentation is by inducing water absorption of gingival fibroblast proliferation. When hyaluronic acid is incorporated into an aqueous solution, hydrogen bonding occurs between adjacent carboxyl and N-acetyl groups; this feature allows hyaluronic acid to maintain conformational stiffness to retain water (Bertl et al. 2017). Also, it may affection collagen remodeling by increasing the production of procollagens and matrix metalloproteinase-1 secretion by fibroblast (Singh et al. 2013). Hyaluronic acid showed a satisfactory result in regeneration of lost interdental papilla at 6 and 12 months (Ficho et al. 2021).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Subperiosteal hyaluronic acid injection overlay technique |
| Group B | Active comparator | Procedure: Tunneling with connective tissue graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients aged over 18 years. 2. Class I papillary recession according to the Nordland and Tarnow classification system. (Nordland and Tarnow 1998) 3. Patients free from any systemic conditions that may affect healing. (Hamadeh et al. 2024).
- 4. The distance between the contact point to alveolar crest between 5 to 7 mm. 5. Presence of the adjacent teeth. 6. Compliant patients with good oral hygiene.
Key exclusion criteria (2 listed)
- 1. Smokers. 2. Pregnant females. 3. Patients with active periodontal disease. 4. Patients who has spacing or crowding between the teeth to be treated. 5. Abnormal tooth shape or adjacent teeth with caries. 6. Presence of proximal restoration or orthodontic appliances or fixed prosthesis.
- 7. Patients with poor oral hygiene according to plaque index score of 2.0 to 3.0 evaluated according to the criteria of Silness and Loe.
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 |
|---|---|---|
| Subperiosteal hyaluronic acid injection overlay techniqueusing subperiosteal hyaluronic acid injection overlay technique showed promising results in treating lost interdental papilla which needs further assessment to its clinical effectiveness | Procedure or surgery | Group A |
| Tunneling with connective tissue graft.Connective tissue graft base techniques have been for years the most predictable approach for treatment of interdental papillary defects. CTG can as a biological filler which enhances flap stability and wound strength. CTG also can promote coagulation cascade and protects the maturating fibrin clot (Tavelli et al. 2019). Moreover, CTG results in significant increase in gingival tissue thickness which positively improve tissue fill and soft tissue volume creeping which influence esthetic outcomes following periodontal regeneration | Procedure or surgery | Group B |
Primary outcome
Changes in papilla height
Time frame: Changes will be recorded at 3, 6 and 12 months
Clinical changes in papilla will be recorded by measuring papilla height at the distance between the tip of the papilla and the incisal edge of the adjacent tooth using UNC periodontal probe .
7 secondary outcomes
Percentage of changes in papilla height
Time frame: 3, 6 and 12 months
Papilla presence index
Time frame: 3, 6 and 12 months
Clinical attachment loss
Time frame: 3, 6 and 12 months
Gingival thickness
Time frame: 3, 6 and 12 months
Post-operative pain
Time frame: 1,3 and 10 days post-surgical.
Patients' esthetic satisfaction
Time frame: 12 months
The need for analgesics
Time frame: 10 days
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 21 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Interdental Papillae Reconstruction
Not yet recruitingPhase 1/2
Clinical Evaluation of Photobiomodulated Hyaluronic Acid Therapy for Interdental Papillary Loss: Minimal Invasive Blind Split Mouth Technique
Interdental Papillae Reconstruction
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.
Questions about this trial
What is this clinical trial studying?
A study testing Subperiosteal hyaluronic acid injection overlay technique and Tunneling with connective tissue graft. in people with Interdental Papillae Reconstruction and Hyaluronic Acid, run by Cairo 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 21 Mar 2025. 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?
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?
Contact Mostafa A Ghoneim, Master's degree (+201115701116, mostafa.amgad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in papilla height (time frame: Changes will be recorded at 3, 6 and 12 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 21 Mar 2025.