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The goal of this clinical trial is to learn if the use of cyanoacrylate glue (PeriAcryl) is effective in healing of the palatal donor site in adults requiring a free gingival graft.
The main question[s] it aims to answer [is/are]:
Does PeriAcryl accelerate the palatal tissue healing compared with the use of collagen sponge? Does PeriAcryl usage leave the patients more satisfied?
Researcher will compare the outcomes of participants treated with PeriAcryl to those treated with collagen sponge to see if PeriAcryl accelerated the healing process of palatal tissues and led to fewer postoperative complications.
Participants will:
This study investigates new approaches to make management of the palatal donor area easier to the operator and more comfortable to the patient. More specifically, it compares the use of PeriAcryl glue (PA) to the use of collagen sponge after harvesting a free gingival graft from the palate in terms of wound healing and epithelization primarily, and patients satisfaction and oral health related quality of life secondarily.
Participants selection:
Healthy patients (with no systemic diseases or coagulation disorders) requiring a free gingival graft to treat a gingival recession or keratinized tissue deficiency around implants and natural teeth will be recruited.
Participants included in this study must have clinically healthy gingiva and good oral hygiene.
Participants grouping:
All the procedures will be achieved with the full knowledge and consent of the patient. A written informed consent will be obtained for each patient included in this study.
Surgical Protocol:
Post-operative Care:
All patients will get the same prescription of antibiotics (Amoxiclave 1g) twice daily for 7 days, and Ibuprofen 600 mg every 8 hours only taken when needed. As well as chlorohexidine 0.12% mouthwash twice daily for 2 weeks.
The same instructions will be given to all the patients (cease smoking, soft diet, oral hygiene, not brushing hard and causing trauma to the surgical site...).
The test group participants receiving PA in the palatal donor will be informed about the material and that it will disintegrate on its own after 10 days.
While the control group participants receiving collagen sponge with (x) sutures in the palatal donor will be informed that the sutures will be removed after 2 weeks.
Following the operation, a questionnaire will be given to each patient asking them to record any spontaneous bleeding of the surgical incision during the first seven days following the procedure, as well as to rate their level of postoperative discomfort using a visual analogue scale (VAS), quantity of analgesics taken, and other questions related to quality of life.
Follow-ups:
All patients will be followed-up at 7, 14, 21 days, 1 month, 2 months, and 3 months, to evaluate healing up to the formation of the first epithelial layer as evaluated by pressure with a periodontal probe and Laundry wound healing index, and the time of complete integrity of the treated palatal fibromucosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen sponge | Active Comparator | Participants will be treated with collagen sponge at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then a collagen sponge will be placed and stabilized with 4/0 silk (x) sutures. |
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| Cyanoacrylate tissue adhesive | Experimental | Participants will be treated with cyanoacrylate tissue adhesive (PeriAcryl) at the palatal donor wound to achieve hemostasis. After FGG harvest, pressure will be applied at the palatal wound using a gauze soaked in saline to top the bleeding, then PeriAcryl will be applied with a pipette following manufacturer's instructions on the entire area of the wound. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate tissue adhesive | Combination Product | Cyanoacrylate tissue adhesive is a chemical synthetic and hybrid tissue sealant possessing strong, rapid acting adhesive properties and is often used in general surgery. Recently, cyanoacrylate tissue adhesive has been effectively introduced into dentistry to close wounds and stop ischemic areas from forming in periodontal aesthetic surgeries. As well as in exposed membranes to preserve the bone graft after guided bone regeneration, in post-extraction sockets, and to seal any surgical flap. This material has strong hemostatic, bacteriostatic, and sealing qualities. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of palatal wound | Healing will be evaluated using Laundry Wound Healing Index (WHI). WHI has a score range of 1 (very poor) to 5 (excellent), evaluates tissue color, response to palpation, presence of granulation tissue, epithelialization of incision margins, and amount of suppuration. | 1 month, 2 months and 3 months post-operatively. |
| Epithelization of the palatal wound | The complete epithelialization will be evaluated clinically by applying 3% hydrogen peroxide into the palatal wound. If bubble formation is not observed, epithelization will be recorded as complete, whereas if bubbles are observed, epithelization will be recorded as incomplete. | On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively. |
| Color Match | Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching). | 3 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain | Postoperative pain will be evaluated on a Visual analogue scale VAS (0 = no pain to 10 = worst imaginable pain). | Every day for 7 days, and on the 14th day. |
| Inflammation Degree |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dania EL Rostom, MSc Oral and Dental Surgery | Contact | +96171659355 | daniarostom1999@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nayer Aboelsaad | Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beirut Arab University | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Collagen sponge | Device | Collagen sponge is an organic polymer that promotes the development of blood clots, and it resorbs quickly and completely over time. Collagen sponge create a matrix at the bleeding site, encourage platelet activation and aggregation, and engage the extrinsic coagulation pathway. Thus, it can be utilized as the first choice for wound healing. |
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Inflammation degree will be measured on a verbal rating scale (VRS) (0 = no inflammation, 1 = mild inflammation, 2 = marked inflammation, and 3 = extreme inflammation).
| Every day for 7 days, and on the 14th day. |
| Post-operative Bleeding | Spontaneous bleeding or postoperative delayed bleeding will be assessed (no: no spontaneous bleeding/yes: there is spontaneous bleeding). | Every day for 7 days, and on the 14th day. |
| Presence of Hyperesthesia | Presence of hyperesthesia will be evaluated using a Verbal Rating Scale VRS (1 = none; 2 = mild, with no interference in normal life activities; and 3 = severe, with interference in normal life activities). | Every day for 7 days, and on the 14th day. |
| Number of Analgesic Pills Taken | Number of analgesic pills taken by the patient post-operatively will be recorded. Minimal amount of analgesic pills taken indicate minimal post-operative pain, whereas excess use of analgesic pills indicate increased post-operative pain. | During the first 14 days post-operatively. |
| Oral Health related Quality of Life | A questionnaire will be given to the participants to evaluate how the surgery affected patients' daily activities, physical state, psychological state, and oral hygiene performance. The questions will be answered with very often, fairly often, occasionally, hardly ever, never, and don't know. | During the first 14 days post-operatively. |