Condition category
Ear, Nose and Throat
Date applied
22/01/2018
Date assigned
15/02/2018
Last edited
15/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gingival recession (also known as receding gums) is when the roots of the teeth are exposed when the gum tissue it lost. One of the main treatments is a gum transplant, where gum tissue (called a graft) is collected from other parts of the mouth and placed on the areas where the gums have receded. There are many different surgical techniques used described to obtain a connective tissue graft from the palate in order to decrease patient discomfort, but there is no clear answer about the influence of the suture technique and the residual flap thickness on the early healing of the donor site. The aim of this study is to examine if wound healing is related to suturing, and if palatial thickness is related to postoperative pain.

Who can participate?
Adults aged 18 and older who have gingival recession.

What does the study involve?
All participants undergo a procedure where a connective tissue graft is taken from the palate using a single incision technique. Participants are randomly allocated to one of two groups. Those in the first group have the donor site sutured with one method. Those in the second group receive a criss-cross suture used. The same drug therapy is given to all patients. One week after surgery, at suture removal, the healing of the donor site is evaluated.

What are the possible benefits and risks of participating?
There are no direct benefits or risks taking part in the study.

Where is the study run from?
Universitat internacional de Catalunya (Spain)

When is the study starting and how long is it expected to run for?
September 2015 to May 2017

Who is funding the study?
Universitat Internacional de Catalunya (Spain)

Who is the main contact?
Dr Giovanni Maino (Public)

Trial website

Contact information

Type

Public

Primary contact

Dr Giovanni Maino

ORCID ID

Contact details

Josep Trueta Street
s/n
Hospital Universitari General de Catalunya
Vicenza
08195
Italy

Type

Scientific

Additional contact

Dr Cristina Valles

ORCID ID

Contact details

calle Josep tureta
Barcelona
08190
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PER-ECL-2015-03

Study information

Scientific title

Influence of suturing technique and postoperative palatal flap thickness on wound healing and patient morbidity after connective tissue harvesting. A randomized controlled clinical trial

Acronym

Study hypothesis

1. Wound healing is correlated to the suturing techniques
2. The post-operative palatal thickness is correlated with the early wound healing of the donor site
3. Palatal thickness is correlated with postoperative pain

Ethics approval

Comitè Etic d'Investigacio Clinica, 20/11/2015, ref: PER-ECL-2015-03

Study design

Single centre randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Palatal healing

Intervention

Using a computerized randomisation method, participants are allocated to one of two groups.

Group 1: Participants receive a continuous interlocking suture used in the donor site
Group 2: Participants receive a criss-cross suture used in the donor site.

The envelope indicating the group to which the patient belongs was opened at the time of the suture. Before the surgery measurement of the palate was taken with and endodontic file and flowable light curing composite. After the obtention of a standardized connective tissue graft (12mm x 8mm x 1,5mm) using the single incision technique, measurement of the residual flap thickness was taken with the same method explained before.

After one week, healing of the donor site is evaluated and pain perception recorded daily until 8 weeks after the intervention.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Association between suture technique and early healing index is measured one week after surgery and after suture removal, the early-wound healing index (EHI) using five different degrees:
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 (more than 50 % of the former flap is involved)

Secondary outcome measures

1. Association between preoperative palatal thickness and early healing is measured one week after surgery using a early-wound healing index (EHI) (Fickl et al. 2014) and the preoperative measurement taken with the endodontic file and light curing flowable composite
2. Association between postoperative palatal flap thickness and early healing is measured one week after surgery using a early-wound healing index (EHI) (Fickl et al. 2014) and the postoperative measurement taken with the endodontic file and light curing flowable composite
3. Pain Perception of the patients was determined with VAS pain values daily until 8 weeks after surgery

Overall trial start date

20/09/2015

Overall trial end date

20/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Men and women over 18 years old
2. Showing Miller Class I,II or III (Miller 1985) single gingival recession

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 patients total, 20 each group

Participant exclusion criteria

1. Any systemic conditions that might impact directly on the systemic inflammatory status (e.g.autoimmune diseases)
2. Severe cognitive or psychiatric disorders
3. Chronic immunosuppressant therapy
4. Lactating females and current pregnancy
5. Patients with coagulation disorders excluded from the trial
6. Smokers who consume more than 10 cigarettes per day
7. Patients using partial or full denture, which has any contact with the palate

Recruitment start date

21/10/2015

Recruitment end date

20/02/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Universitat Internacional de Catalunya
Calle Josep Tureta s/n
Barcelona
08190
Spain

Sponsor information

Organisation

Universitat Internacional de Catalunya

Sponsor details

Calle Josep Tureta
San Cugat del Valles
08195
Spain
+34 93 504 20 30
clinica@uic.es

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universitat Internacional de Catalunya

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

15/07/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes