Comparison of Connective Tissue Graft Versus Titanium Papillary Inserts in the Surgical Reconstru… (NCT07401667) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Connective Tissue Graft Versus Titanium Papillary Inserts in the Surgical Reconstruction of Interdental Papilla.
India18 participantsStarted 2023-05-21
Plain-language summary
Aim and Objectives: The study aimed to evaluate the effectiveness of titanium inserts for interdental papilla reconstruction, comparing it with the Han and Takei technique using subepithelial connective tissue grafts. The objectives included assessing the black triangle height, papilla height and papilla presence index (PPI) at baseline, 1 month and 3 months post operatively along with the evaluation of Early Wound Healing Score (EHS) during the first week of post operative healing period. Patients and Methods: This single-blind randomized clinical trial included systemically healthy individuals aged 18-35 years with Nordland and Tarnow's Class I-III papillary loss. A total of 18 participants were randomly assigned to either test group or control group. Clinical parameters were measured pre- and post-operatively at specified intervals. Both groups received standard presurgical care and postoperative follow-up. The surgical protocol for the test group involved titanium insert placement in the interdental bone, while the control group received a connective tissue graft using the Han and Takei method.
Who can participate
Age range
18 Years – 35 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:
* Systemically healthy male and female patients with a stable periodontal health of age 18-35 years.
* Patients with Nordland and Tarnow's1 Class I, II, III interdental papillary loss at a single site and Gingival recession \< 2 mm on the facial aspect.
* Patients presenting with adequate width of attached gingiva (2-3mm)
* Having a thick gingival biotype (2 mm)
Exclusion Criteria:
* Midline diastema patients
* Medically compromised patients
* Pregnant and lactating women
* Heavy smokers,
* Patient who underwent radiotherapy \& chemotherapy,
* Patients with any bleeding or clotting disorders
* Patients not willing to participate in the study.
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.