Pain, PostoperativeNCT06408792
To Evaluate Postoperative Pain and Quality of Life After Taking a Deephethelized Gingival Graft and Covering it With Different Treatments
A study testing Deepithelized graft and protection technique in people with Pain, Postoperative and Quality of Life, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Objective: To evaluate postoperative pain and quality of life in relation to oral health after obtaining a palatal de-epithelialized gingival graft and subsequent coverage of the surgical wound with an adhesive film of cellulose and fluid composite versus a palatal plate or covering with cyanoacrylate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Quality of Life, Palate; Wound
- What is being tested?
- Deepithelized graft and protection technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years.
- Need for soft tissue augmentation in an edentulous space to increase gingival volume simultaneously with placing a dental implant.
- Patients with a palatal thickness of at least 4mm. This will be measured by overlaying a DICOM file of the CBCT with an STL file of the intraoral scan (Shining 3D). It will be measured at the height of the maxillary 2nd premolar, 5mm from the gingival margin.
- Patients in whom a de-epithelialized palatal graft measuring 12x5mm can be obtained and which is between 1.5-2mm thick. The thickness will be measured with a digital caliper once it has been de-epithelialized.
- Patients with no history of previous palatal graft extraction.
- Patients with the ability to comply with the procedures related to the study, such as maintaining good oral hygiene, filling out the questionnaires and attending follow-up appointments.
- Patients with the ability to fully understand the nature of the proposed surgery and the ability to understand and sign the informed consent form.
Who cannot join
- Presence of vertical bone dehiscence of >3mm in the buccal area of the edentulous space where the implant will be placed (assessed at the time of surgery).
- Smokers of more than 10 cigarettes/day
- Presence of untreated periodontitis.
- Diabetics
- Patients being treated with oral anticoagulants or antiplatelet agents.
- Patients with a history of malignant tumors, head and neck radiotherapy, chemotherapy or immunotherapy treatment in the last 5 years.
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- Patients with a history of previous or current medication that affects wound healing or promotes the appearance of infections, such as the use of corticosteroids, immunosuppressants or immunomodulators.
- Patients with diseases that affect the metabolism of connective tissue, autoimmune or chronic inflammatory diseases with oral involvement (oral lichen planus, mucosal pemphigoid, pemphigus...), alterations in vascularization in the donor or recipient area, metabolic bone diseases or abuse of alcohol.
- Patients receiving antiresorptive drugs such as bisphosphonates, denosumab, romosozumab or other drugs associated with osteonecrosis due to drugs such as m-TOR inhibitors, bevacizumab and sunitinib.
- Pregnant or breastfeeding women.
- Presence of oral lesions on the palate such as recurrent lesions due to herpes simplex virus.
- Patients who use removable dental prosthesis that covers the palate.
- Patients with a history of hypersensitivity to any of the materials used in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Dental Doctores Garcia Ruiz e Iglesias Esquiroz
Alcorcón, Madrid, 28921
sergio garcia moreno, 649985148, sergiog.moreno9@gmail.com
About this study
Official title: Randomized Controlled Tiral to Evaluate Postoperative Pain and Quality of Life in Relation to Oral Health After Taking a Deephethelized Gingival Graft and Covering it With an Adhesive Film of Cellulose and Fluid Composite in Comparison With a Palate Plate or Cyanocrylate.
Objective: To evaluate postoperative pain and quality of life in relation to oral health after obtaining a palatal de-epithelialized gingival graft and subsequent coverage of the surgical wound with an adhesive film of cellulose and fluid composite versus a palatal plate or covering with cyanoacrylate.
Study design: Randomized controlled study.
Read more
Patients: Patients who require a de-epithelialized gingival graft will be selected from two private clinics in the Community of Madrid.
Allocation: Patients will be randomly assigned to the study group (cellulose film and flowable composite), control group 1 (palatal plank) or control group 2 (cyanoacrylate coverage).
Variables: Postoperative pain will be recorded using a 10 cm visual analogue scale (VAS) and analgesic consumption will be noted. Quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Analysis plan: Descriptive statistics will be used to describe patient characteristics. The possible differences between the 3 study groups will be evaluated using parametric or non-parametric tests depending on the distribution of the variables.
- Conditions
- Pain, Postoperative, Quality of Life, Palate; Wound
- Being tested
- Deepithelized graft and protection technique
- Medical subject headings
- Pain, Postoperative, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deepithelized graft and protection techniqueDevice
To obtain the graft in all cases, on the day of surgery, 4% articaine with epinephrine 1:100,000 will be administered to block the greater palatine nerve. Gingival grafts from all groups will be deepithelialized intraorally using a sterile 834 turbine diamond bur. This drill will go deeper into the palatal mucosa 0.5mm (half of the outermost active part of the drill). The gingival grafts will be obtained with the surgical technique described by Zucchelli et al. 2010.
| Study group | Role | What they receive |
|---|---|---|
| Cellulose (OraAid) and fluid composite | Experimental | In this case, collagen sponges will be placed in the palatal wound, then the cellulose adhesive film (OraAid) will be placed on top, and this will be covered by fluid composite adhered to the teeth on their palatal wall.
Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. Receives: Device: Deepithelized graft and protection technique |
| Palate plate | Active comparator | In this case, collagen sponges will be placed in the palatal wound, held in place by sutures, and the palatal wound will be covered with a custom-made palatal plate made just after surgery.
Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. Receives: Device: Deepithelized graft and protection technique |
| Cyanocrylate (periacril) | Active comparator | In this case, collagen sponges will be placed in the palatal wound held by sutures and the palatal wound will be covered with cyanoacrylate tissue adhesive (Periacryl 90).
Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. Receives: Device: Deepithelized graft and protection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction assessed by the Visual Analog Scale in the palate
Visual analog escale from 0 (the minimun and best score) to 10 (the maximum and worst pain score)
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
Satisfaction assessed by analgesic pills consumption
Number of Ibuprofens 600mg every 8hours (if needed) taken
Measured: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
Secondary outcomes (4)
Satisfaction assessed by Oral Health Impact Profile 14 (OHIP-14)
OHIP-14 questionnaire: 0 means the best score and 56 the maximum and worst score
Measured: day 0, day 3, day 7, day 14
Hematoma assessed by the patient
yes / no
Measured: Assessed day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 after the surgery
Swelling assessed by the patient
yes / no
Measured: Assessed day 1, day 2, day 3,day 4, day 5, day 6, day 7, day 10,day 14 after the surgery
Palate bleeding assessed by the patient
yes/no
Measured: Assessed before and after 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start2 Apr 2024
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa López-Pintor, Professor, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408792
- Sponsor's protocol ID
- 24/175-EC_X
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Moreno S, Lopez-Pintor RM, Leco-Berrocal I, Torres J, Gonzalez-Serrano J. Impact of a Bioadhesive Oral Wound Dressing Combined With Flowable Resin on Patient-Reported Outcomes After Palatal Graft Harvesting: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Mar;37(3):303-313. doi: 10.1111/clr.70070. Epub 2025 Nov 10.
PubMed 41212657
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Tiral to Evaluate Postoperative Pain and Quality of Life in Relation to Oral Health After Taking a Deephethelized Gingival Graft and Covering it With an Adhesive Film of Cellulose and Fluid Composite in Comparison With a Palate Plate or Cyanocrylate.
- ClinicalTrials.gov ID
- NCT06408792
- Acronym / sponsor ID
- 24/175-EC_X
- Conditions
- Pain, Postoperative, Quality of Life, Palate; Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To evaluate postoperative pain and quality of life in relation to oral health after obtaining a palatal de-epithelialized gingival graft and subsequent coverage of the surgical wound with an adhesive film of cellulose and fluid composite versus a palatal plate or covering with cyanoacrylate.
Study design: Randomized controlled study.
Patients: Patients who require a de-epithelialized gingival graft will be selected from two private clinics in the Community of Madrid.
Allocation: Patients will be randomly assigned to the study group (cellulose film and flowable composite), control group 1 (palatal plank) or control group 2 (cyanoacrylate coverage).
Variables: Postoperative pain will be recorded using a 10 cm visual analogue scale (VAS) and analgesic consumption will be noted. Quality of life in relation to oral health will be recorded using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.
Analysis plan: Descriptive statistics will be used to describe patient characteristics. The possible differences between the 3 study groups will be evaluated using parametric or non-parametric tests depending on the distribution of the variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cellulose (OraAid) and fluid composite | Experimental | Device: Deepithelized graft and protection techniqueIn this case, collagen sponges will be placed in the palatal wound, then the cellulose adhesive film (OraAid) will be placed on top, and this will be covered by fluid composite adhered to the teeth on their palatal wall. Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
| Palate plate | Active comparator | Device: Deepithelized graft and protection techniqueIn this case, collagen sponges will be placed in the palatal wound, held in place by sutures, and the palatal wound will be covered with a custom-made palatal plate made just after surgery. Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
| Cyanocrylate (periacril) | Active comparator | Device: Deepithelized graft and protection techniqueIn this case, collagen sponges will be placed in the palatal wound held by sutures and the palatal wound will be covered with cyanoacrylate tissue adhesive (Periacryl 90). Amoxicillin 750mg 1pill each 8hours during 7 days. Ibuprofen 600mg 1pill each 8hours when needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥18 years.
- Need for soft tissue augmentation in an edentulous space to increase gingival volume simultaneously with placing a dental implant.
- Patients with a palatal thickness of at least 4mm. This will be measured by overlaying a DICOM file of the CBCT with an STL file of the intraoral scan (Shining 3D). It will be measured at the height of the maxillary 2nd premolar, 5mm from the gingival margin.
- Patients in whom a de-epithelialized palatal graft measuring 12x5mm can be obtained and which is between 1.5-2mm thick. The thickness will be measured with a digital caliper once it has been de-epithelialized.
- Patients with no history of previous palatal graft extraction.
Key exclusion criteria (13 listed)
- Presence of vertical bone dehiscence of >3mm in the buccal area of the edentulous space where the implant will be placed (assessed at the time of surgery).
- Smokers of more than 10 cigarettes/day
- Presence of untreated periodontitis.
- Diabetics
- Patients being treated with oral anticoagulants or antiplatelet agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deepithelized graft and protection techniqueTo obtain the graft in all cases, on the day of surgery, 4% articaine with epinephrine 1:100,000 will be administered to block the greater palatine nerve. Gingival grafts from all groups will be deepithelialized intraorally using a sterile 834 turbine diamond bur. This drill will go deeper into the palatal mucosa 0.5mm (half of the outermost active part of the drill). The gingival grafts will be obtained with the surgical technique described by Zucchelli et al. 2010. | Device | Cellulose (OraAid) and fluid composite, Cyanocrylate (periacril), Palate plate |
Primary outcome
Satisfaction assessed by the Visual Analog Scale in the palate
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
Visual analog escale from 0 (the minimun and best score) to 10 (the maximum and worst pain score)
Satisfaction assessed by analgesic pills consumption
Time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14
Number of Ibuprofens 600mg every 8hours (if needed) taken
4 secondary outcomes
Satisfaction assessed by Oral Health Impact Profile 14 (OHIP-14)
Time frame: day 0, day 3, day 7, day 14
Hematoma assessed by the patient
Time frame: Assessed day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10 after the surgery
Swelling assessed by the patient
Time frame: Assessed day 1, day 2, day 3,day 4, day 5, day 6, day 7, day 10,day 14 after the surgery
Palate bleeding assessed by the patient
Time frame: Assessed before and after 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 41212657Garcia-Moreno S, Lopez-Pintor RM, Leco-Berrocal I, Torres J, Gonzalez-Serrano J. Impact of a Bioadhesive Oral Wound Dressing Combined With Flowable Resin on Patient-Reported Outcomes After Palatal Graft Harvesting: A Randomized Clinical Trial. Clin Oral Implants Res. 2026 Mar;37(3):303-313. doi: 10.1111/clr.70070. Epub 2025 Nov 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa López-Pintor, Professor principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deepithelized graft and protection technique in people with Pain, Postoperative and Quality of Life, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José González Serrano, PhD (+34662293482, josego09@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction assessed by the Visual Analog Scale in the palate (time frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 10, day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06408792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.