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The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes.
The main questions it aims to answer are:
Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free gingival grafting (FGG) using titanium tacks for stabilization | Experimental | According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots. The FGG will be stretched by fixing one tack at its distal end, then another tack at its mesial one, followed by the other tacks as required. |
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| Free gingival grafting (FGG) using sutures for stabilization | Active Comparator | Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free gingival grafting (FGG) using titanium tacks for stabilization | Procedure | According to the graft size, 2 to 5 titanium tacks will be used to stabilize and secure the free gingival graft in place to the periosteum at the recipient bed as needed, through anchoring in inter-septal bone and avoiding teeth roots. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 1 week postoperatively. | Daily for the first 7 days post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinized tissue width (KTW) | Will be measured from the MGJ to the free gingival margin. The MGJ will be identified using the roll technique. | Week 12, Week 24 |
| Intra-operative/procedure time (PT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry and Oral Medicine, Cairo University, Cairo. | Recruiting | Cairo | Cairo Governorate | 11553 | Egypt |
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| Free gingival grafting (FGG) using sutures for stabilization. | Procedure | Stabilization of the free gingival autograft in place using a 5-0 or 6-0 resorbable Prolene suture using a combination of two interrupted sutures, anchoring the grafted tissue to the base of the anatomical papillae, and a horizontal mattress compression suture anchored to the periosteum apical to the bone dehiscence and suspended around the palatal or lingual cingulum of the tooth with the recession defect, allowing for intimate contact ensuring proper perfusion and consequent revascularization of the graft. |
|
Will be measured using a stopwatch from the beginning till the end of each procedure.
| During the free gingival graft stabilization procedure |
| Daily life interference | It is based on the level of interference of surgical procedure on the patient's normal daily life for the first week after surgery. | Daily for the first 7 days post-surgery. |
| Gingival thickness | An endodontic file and a 3 mm diametersilicon disc stop will be used to measure gingival thickness 2mm apical to the gingival border. The file will be inserted into the soft tissue with mild pressure, perpendicular to the mucosal surface, until a firm surface is felt. The silicon disc stop will be then pressed against the soft tissue, with the coronal border covering the soft tissue boundary. | Week 12, Weeks 24. |
| Post-operative Pain [Indirect] | It is based on the amount of analgesics patient consumes, only if needed, during the first week after surgery. This will be measured by the number of pills consumed by the patient after both the pretreatment and 6h post-treatment doses. | Daily for the first 7 days post-surgery. |
| Plaque Index |
| Week 12, Week 24. |
| Graft dimensions | Will be measured from standardized images using "Image J Software" for standardization of measurements and readings. | Week 12, Week 24. |
| ID | Term |
|---|---|
| C027539 | fibrinopeptides gamma |
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