Wound HealingNCT04513886

Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture

A study testing Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate in people with Wound Healing, run by Mariel Viviana Gómez at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluated the outcomes in the early healing of palatal wounds after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique with placement of a collagen haemostatic sponge (CHS) without suturing the palate. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Wound Healing
What is being tested?: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteArgentina
Study dates: 19 Nov 2018to 26 Aug 2019
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects with an indication of mucogingival surgery for single gingival recession treatment that required harvesting a subepithelial connective tissue graft
Age >18 years ≤ 60 years.
Periodontally and systemically healthy.
Palatal fibromucosa width ≥ 2mm evaluated with a North Carolina probe placed perpendicular to the hard palate, prior to surgery.

Who cannot join

Smoking.
Contraindications for periodontal surgery.
Subjects presenting coagulation disorders (history of Haemophilia, von Willebrand disease or anticoagulant therapy).
Subjects taking medications known to interfere with periodontal tissue health or healing.
Subjects that had been operated on the palate (connective tissue removed) previously from that same donor area.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Maimonides University
Buenos Aires, Buenos Aires F.D., 1405

Other trials in Argentina

About this study

Official title: Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial

Read the detailed description

The aim of this study was to compare the outcomes in the early wound healing after harvesting a subepithelial connective tissue graft (SCTG) using the single incision technique and collagen haemostatic sponge (CHS) placement, with and without suturing the palate. 36 subjects were randomized to receive (n=18, Suture group-SG) or not a suture (n=18, no Suture group-nSG). Outcomes variables were: Early healing index (EHI) at 7, 14 and 30 days, self-reported pain using a visual analogue scale (VAS) at 7 and 14 days, immediate (iB) and delayed bleeding (dB). Data obtained were compared by Fisher's exact test, T test for independent sample, Mann-Whitney test (U test) and Wilcoxon sign test as appropriate. The level of significance was set at p < 0.05. Statistical analysis was performed with Infostat version 2015.

Conditions: Wound Healing
Being tested: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate
Keywords: wound healing, palate, connective tissue harvesting, single incision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palateProcedure or surgery
A SCTG was harvested using the single incision technique described by Hürzeler \& Weng. The palatal incisions were standardized to extend between the area between mesial of the canine and mesial of the first molar.In the Suture Group sites a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate. In the no Suture Group sites, no suture was performed. In both groups, a CHS was placed after removing the graft to achieve the haemostasis of the palate and subsequent compressed with gauze soaked in saline for 5 minutes.

Study groups in NCT04513886
Study group	Role	What they receive
Suture Group	Active comparator	After harvesting a subepithelial connective tissue graft using the single incision technique collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes, a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate. Receives: Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate
no Suture Group	Experimental	After harvesting a subepithelial connective tissue graft using the single incision technique, collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes no suture was performed. Receives: Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate

What is being measured

The primary outcome is the main question the study is designed to answer.

Early healing index
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
Measured: Day 7 post surgery
Early healing index
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
Measured: Day 14 post surgery
Early healing index
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
Measured: Day 30 post surgery

Secondary outcomes (4)

Number of participants with immediate bleeding
An embedded gauze with saline was pressed on the palate wound for 5 minutes in both groups. Positive iB was recorded if once the gauze was removed, bleeding persisted. Compression was repeated as many times as necessary until bleeding was arrested. If this maneuver was not enough, additional actions should be performed to stop bleeding and the patient would be excluded from the study.
Measured: immediately postsurgery
Number of participants with delayed bleeding
Any type of bleeding from the palatal area reported during the postoperative period was recorded as positive
Measured: 7 days post surgery
Pain level / discomfort
Pain level / discomfort experienced at the surgical site of the palate, was self-reported by the subject and registered with a Visual Analogue Scale (VAS). It was required to the subject to graduate their sensitivity using a scale of 10 cm marked in mm between 0 and 100, labelled numerically from 0 to 10. Zero corresponds to "no discomfort" and 10 "unbearable pain". All other possible adverse effects were also recorded.
Measured: first week after surgery,
Pain level / discomfort
Pain level / discomfort experienced at the surgical site of the palate, was self-reported by the subject and registered with a Visual Analogue Scale (VAS). It was required to the subject to graduate their sensitivity using a scale of 10 cm marked in mm between 0 and 100, labelled numerically from 0 to 10. Zero corresponds to "no discomfort" and 10 "unbearable pain". All other possible adverse effects were also recorded.
Measured: second week after surgery,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Nov 201826 Aug 2019

First posted14 Aug 2020
Study start19 Nov 2018
Primary completion26 Aug 2019
Study completion26 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Wound HealingStudies of the same condition, open and under way.
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
Model description: Participants were assigned to one of two groups in parallel for the duration of the study: This study was a non-masked, randomized, controlled clinical trial, with a parallel design, comparing early healing of palatal wounds after harvesting subepithelial connective tissue graft using the single incision technique, with and without palatal sutures.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04513886
Sponsor's protocol ID: 2310/18
Status last verified: Aug 2020
First submitted: 10 Aug 2020
Last updated: 14 Aug 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Maino GNE, Valles C, Santos A, Pascual A, Esquinas C, Nart J. Influence of suturing technique on wound healing and patient morbidity after connective tissue harvesting. A randomized clinical trial. J Clin Periodontol. 2018 Aug;45(8):977-985. doi: 10.1111/jcpe.12960. Epub 2018 Jul 24.
PubMed 29908088
Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26.
PubMed 30517975
Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.
PubMed 11203571
Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.
PubMed 24562700
Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.
PubMed 31104113
Rossmann JA, Rees TD. A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding. J Periodontol. 1999 Nov;70(11):1369-75. doi: 10.1902/jop.1999.70.11.1369.
PubMed 10588501
Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
PubMed 18315424
Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
PubMed 12423299
Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
PubMed 10635174

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Healing After Connective Tissue Graft Harvesting in the Palatal Area With and Without Suture: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04513886
Acronym / sponsor ID: 2310/18
Conditions: Wound Healing
Keywords: wound healing, palate, connective tissue harvesting, single incision
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Mariel Viviana GómezUniversity, hospital or other
Collaborators: Maimonides University
Study start: 19 Nov 2018 (actual)
Primary completion: 26 Aug 2019 (actual)
Study completion: 26 Aug 2019 (actual)
First posted: 14 Aug 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants were assigned to one of two groups in parallel for the duration of the study: This study was a non-masked, randomized, controlled clinical trial, with a parallel design, comparing early healing of palatal wounds after harvesting subepithelial connective tissue graft using the single incision technique, with and without palatal sutures.

Arm	Type	Receives
Suture Group	Active comparator	Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palateAfter harvesting a subepithelial connective tissue graft using the single incision technique collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes, a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate.
no Suture Group	Experimental	Procedure: Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palateAfter harvesting a subepithelial connective tissue graft using the single incision technique, collagen haemostatic sponge placement and subsequent compression with gauze soaked in saline for 5 minutes no suture was performed.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subjects with an indication of mucogingival surgery for single gingival recession treatment that required harvesting a subepithelial connective tissue graft
Age >18 years ≤ 60 years.
Periodontally and systemically healthy.
Palatal fibromucosa width ≥ 2mm evaluated with a North Carolina probe placed perpendicular to the hard palate, prior to surgery.

Key exclusion criteria (5 listed)

Smoking.
Contraindications for periodontal surgery.
Subjects presenting coagulation disorders (history of Haemophilia, von Willebrand disease or anticoagulant therapy).
Subjects taking medications known to interfere with periodontal tissue health or healing.
Subjects that had been operated on the palate (connective tissue removed) previously from that same donor area.

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
Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palateA SCTG was harvested using the single incision technique described by Hürzeler \& Weng. The palatal incisions were standardized to extend between the area between mesial of the canine and mesial of the first molar.In the Suture Group sites a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate. In the no Suture Group sites, no suture was performed. In both groups, a CHS was placed after removing the graft to achieve the haemostasis of the palate and subsequent compressed with gauze soaked in saline for 5 minutes.	Procedure or surgery	Suture Group, no Suture Group

Primary outcome

Early healing index
Time frame: Day 7 post surgery
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
Early healing index
Time frame: Day 14 post surgery
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.
Early healing index
Time frame: Day 30 post surgery
1. Complete flap closure without fibrin line at the palate; 2. Complete flap closure with fibrin line at the palate; 3. Complete flap closure with small fibrin clot(s) at the palate; 4. Incomplete flap closure with partial necrosis of the palatal tissue; 5. Incomplete flap closure with complete necrosis of the palatal tissue.

4 secondary outcomes

Number of participants with immediate bleeding
Time frame: immediately postsurgery
Number of participants with delayed bleeding
Time frame: 7 days post surgery
Pain level / discomfort
Time frame: first week after surgery,
Pain level / discomfort
Time frame: second week after surgery,

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Background: PubMed 29908088Maino GNE, Valles C, Santos A, Pascual A, Esquinas C, Nart J. Influence of suturing technique on wound healing and patient morbidity after connective tissue harvesting. A randomized clinical trial. J Clin Periodontol. 2018 Aug;45(8):977-985. doi: 10.1111/jcpe.12960. Epub 2018 Jul 24.
Background: PubMed 30517975Stavropoulou C, Atout RN, Brownlee M, Schroth RJ, Kelekis-Cholakis A. A randomized clinical trial of cyanoacrylate tissue adhesives in donor site of connective tissue grafts. J Periodontol. 2019 Jun;90(6):608-615. doi: 10.1002/JPER.18-0475. Epub 2018 Dec 26.
Background: PubMed 11203571Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.
Background: PubMed 24562700Fickl S, Fischer KR, Jockel-Schneider Y, Stappert CF, Schlagenhauf U, Kebschull M. Early wound healing and patient morbidity after single-incision vs. trap-door graft harvesting from the palate--a clinical study. Clin Oral Investig. 2014 Dec;18(9):2213-9. doi: 10.1007/s00784-014-1204-7. Epub 2014 Feb 23.
Background: PubMed 31104113Lektemur Alpan A, Torumtay Cin G. PRF improves wound healing and postoperative discomfort after harvesting subepithelial connective tissue graft from palate: a randomized controlled trial. Clin Oral Investig. 2020 Jan;24(1):425-436. doi: 10.1007/s00784-019-02934-9. Epub 2019 May 18.
Background: PubMed 10588501Rossmann JA, Rees TD. A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding. J Periodontol. 1999 Nov;70(11):1369-75. doi: 10.1902/jop.1999.70.11.1369.
Background: PubMed 18315424Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
Background: PubMed 12423299Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
Results publication: PubMed 10635174Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
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.

Mariel V Gómez, Assoc Prof study director

Maimonides University

Guillermo Schinini, Assoc Prof principal investigator

Maimonides University

Hugo J Romanelli, Chair Prof study chair

Maimonides University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2020. 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 Argentina. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early healing index (time frame: Day 7 post surgery). The study lists 3 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 NCT04513886, which also lists 9 linked publications.

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 14 Aug 2020.