Effect of Cyanoacrylate Tissue Adhesive Versus Collagen Sponge on Palatal Donor Site Healing
ConditionPalate; Wound
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeirut Arab University
About this trial
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:
* be assigned to a study group using PeriAcryl or control group using Collagen sponge. * be followed-up to monitor healing and gather clinical information.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Low-moderate anesthetic risk (ASA I-II)
No restriction on ethnicity or gender
Patients requiring FGG from the palate for periodontal plastic surgery
Clinically healthy gingiva after phase I therapy
Disqualifiers
Patients who smoke > 10 cigarettes/day
Patients with coagulation disorders
Systemic diseases
Patients on certain medications that may affect periodontal tissues
Trial design
Design model
Parallel
Treatments tested in this trial
Cyanoacrylate tissue adhesive
Combination productCyanoacrylate 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.
Collagen sponge
DeviceCollagen 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.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: Collagen spongeActive comparator 1 intervention
Group B: Cyanoacrylate tissue adhesiveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month, 2 months and 3 months post-operatively.2
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.
Time frame
On every follow-up session: 7 days, 14 days, 21 days, 1 month, 2 months and 3 months post-operatively.3
Color Match
Tissue color match (CM) will be assessed with adjacent and contralateral palatal tissue (0-no color matching to 10-excellent color matching).
Time frame
3 months post-operativelySecondary outcomes
1
Post-operative Pain
Postoperative pain will be evaluated on a Visual analogue scale VAS (0 = no pain to 10 = worst imaginable pain).
Time frame
Every day for 7 days, and on the 14th day.2
Inflammation Degree
Inflammation degree will be measured on a verbal rating scale (VRS) (0 = no inflammation, 1 = mild inflammation, 2 = marked inflammation, and 3 = extreme inflammation).
Time frame
Every day for 7 days, and on the 14th day.3
Post-operative Bleeding
Spontaneous bleeding or postoperative delayed bleeding will be assessed (no: no spontaneous bleeding/yes: there is spontaneous bleeding).
Time frame
Every day for 7 days, and on the 14th day.4
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).
Time frame
Every day for 7 days, and on the 14th day.Sponsors and contacts
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Source ClinicalTrials.gov