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An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.
An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13, 14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14. PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.7, 8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors. Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration. Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au | Experimental | The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues. |
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| Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti | Active Comparator | The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage | Procedure | The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-implant soft tissue thickness | Volumetric | Time Frame: 6 weeks and 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| width of the keratinized tissue around dental implants | Periodontal probe mm | Time Frame: baseline, 3 and 6 months |
| Marginal bone loss | CBCT measurement |
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-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of < 25%) and with stable periodontal status.
-Exclusion Criteria: Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance.
Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nesma Shemais, PhD | Contact | 0529961988 | dr.nesma@gmu.ac.ae |
| Name | Affiliation | Role |
|---|---|---|
| Nesma MF Shemais | Assistant professor of Periodontology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulf Medical University | Recruiting | Ajman | Ajman Emirate | 00000 | United Arab Emirates |
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| Soft tissue augmentation around dental implants with CTG in the second stage | Procedure | The test group will be treated with dental implant and CTG. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues. |
|
| 6 months |
| Postoperative patient satisfaction VAS 0-5 | VAS 0-5 | baseline, 2 weeks, 6 months |
| ID | Term |
|---|---|
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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