Clinical Evaluation of the Use of Surgical Tube Technique Versus Hyaluronic AcidInjection in Reco… (NCT05235477) | Clinical Trial Compass
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Clinical Evaluation of the Use of Surgical Tube Technique Versus Hyaluronic AcidInjection in Reconstruction of the Interproximal Papilla
Egypt24 participantsStarted 2021-09-09
Plain-language summary
Restoring defective interdental papilla partially or totally in structure and function creates a challenge in dental field owing to the small working space and limited blood supply to the area.
This led to the innovation of different techniques for treatment of defective interdental papilla that aimed at papillary tissue augmentation reported to be attained through influencing connective tissue cell proliferation, providing clot stability, protecting the reconstructed site during wound healing.
Among these techniques is the injection of hyaluronic acid gel have been considered of the latest non-invasive technique to escape drawbacks of surgeries. Though proved to have some positive results in the literature however still entails unpredicted complete gingival papilla improvement because of the diverse injection methods, cycles, dosage, and the course of treatment that needs further optimization, in addition to the lack of unified patient inclusion criteria, especially the gingival biotype .
Several surgical techniques designed to host the richest effective known sub-epithelial connective tissue graft had failed to allow maximum benefit of the graft due to the disadvantages from the number and location of incisions of their flap design, which possibly disrupt the blood supply needed added to unconsidered flap thickness, and flap retraction that impacted the success of soft tissue grafting.
Surgical Tube technique has recently been developed optimizing flap thickness, flap retraction and tension to escape disturbance of the blood supply of the graft by its use of apical incisions and containment of the graft within a rich vascular enclosed bed, thereby offering an attempt to guarantee integrity of soft tissue with no disruption of blood supply.
Who can participate
Age range
25 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Highly motivated patients with papillary deficiency types II, according to Nordland and Tarnow 1998 classification will be selected, having at least one deficient papilla in the anterior region.
* Distance between the contact point and inter-proximal bone crest (CP-BC) of ≤ 7 mm and probing depth of ≤ 4 mm at the deficient papillary site (Abdelraouf etal. 2019).
* Patients with full mouth plaque index (PI) and gingival index (GI) scores should be between 0-1.
* Healthy patients free of any medical condition.
Exclusion Criteria:
* ● Patients with medical conditions that may affect periodontal healing or regeneration.
* Patients with a history of allergic reactions, pregnant or breastfeeding females, smokers and alcoholics.
* Patients with current or previous drugs intake that may predispose to gingival enlargement.
* Patients under orthodontic treatment or had orthodontic treatment in the past six months.
* Carious teeth, proximal restorations or fixed prosthesis.
* Patients with a history of traumatic oral hygiene measures or periodontal surgeries over the last six months at the area of interest or having any scar tissue.
* Poor oral hygiene patients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
interdental papilla loss (Decrease of black triangle area ) (mm2)