Condition category
Oral Health
Date applied
19/11/2018
Date assigned
11/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When gums (gingiva) recede, the roots of the teeth are exposed and the teeth can become loose. Gum recession can be treated by surgically moving (grafting) tissue from the mouth to cover the exposed part of the tooth root. There are several techniques of gingival grafting. This study aims to investigate a technique called apical access, which takes tissue from the roof of the mouth (palate).

Who can participate?
Adults who are otherwise healthy, who have gum recession of several adjacent teeth with the teeth becoming loose and who don't have gum disease or have gum disease that has been treated successfully.

What does the study involve?
Dental patients who have noticed discomfort when brushing their teeth, who have experienced progression of gum recession and who have difficulties in accessing the teeth to keep them clean will be offered apical access grafting. All participants in the study will receive the same treatment. Their teeth and gums will be examined and the recession measured before treatment and at 6 and 12 months after treatment.

What are the possible benefits and risks of participating?
The benefit of participating in the study is the reduction of their gingival recessions. Patients receive the same treatment if they do not participate in the study. There is no additional risk for participating in the study compared with receiving the surgery to correct their gum problems outside of the study.

Where is the study run from?
Periocentrum Bilbao (Spain)

When is the study starting and how long is it expected to run for?
January 2016 to December 2017

Who is funding the study?
Periocentrum Research (Spain)

Who is the main contact?
Dr. Alberto Ortiz-Vigón, alberto@ortizvigon.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alberto Ortiz-Vigón Carnicero

ORCID ID

Contact details

C/ Alameda Urquijo Street n 2 7º floor
bilbao
48008
Spain

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

001

Study information

Scientific title

Periapical tunnel access for mucogingival root coverage: a case series

Acronym

Study hypothesis

Periapical tunnel access for mucogingival root coverage is associated with lower patient morbidity, adequate root coverage and keratinized tissue gain and a greater vestibulum depth gain

Ethics approval

This study does not require ethics approval because it is a routine and habitual technique in those cases in which we have a reduced vestibulum depth associated with low keratinized tissue and gingival recessions

Study design

Observational descriptive case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Multiple gingival recessions type III or Cairo RT2 with a narrow keratinized tissue and a shallow vestibulum

Intervention

Patient receive oral hygiene instructions for at least 2 months before surgery.
As a baseline measurement, a periodontal probe is used to record the length of recession, keratinized tissue and vestibular depth. Intraoral photographs and radiography are also taken.
All surgeries are performed by the same experienced periodontist (Alberto Ortiz-Vigon). An initial semilunar incision is made in the alveolar mucosa. The incision is extended one tooth on either side of the recessions. The flap is elevated with a periostotome to advance it coronally without tension. A connective tissue graft is harvested from the posterior palate by means of a single-incision technique and according to the mesio-distal length of the recessions. The donor site is sutured with a cross-mattress suture. This connective tissue graft is positioned under the flap and the flap is repositioned slightly coronal to the cement-enamel junction, with suspended sutures around the contact points. The apical area is sutured by means of sutures anchored to the periosteum.
Subjects receive detailed written and verbal post-operative instruction. Subjects are instructed to avoid mechanical disturbance of the surgical site for the first week. Oral hygiene instructions include 0.12% chlorhexidine mouth rinses after 24 h and no direct brushing of the surgical site for 4 weeks. No antibiotics are prescribed. An anti-inflammatory (Enantyum 25 mg every 8 h for 3-5 days) is prescribed to all subjects.
Subjects return to the clinic after 2, 4, 26 and 52 weeks. Sutures are removed 2 weeks postoperatively. Photographs will be taken after 2, 26 and 52 weeks. At 52 weeks clinical measurements are repeated with a periodontal probe.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Recession reduction, assessed by the difference between cement enamel junction and gingival margin in baseline and 1 year follow-up. The recession is measured from the cemento- enamel junction (CEJ) to the most apical point of the gingival margin.

Secondary outcome measures

1. Complete root coverage measured at 6 months and 12 months after surgical procedure with a CP15 periodontal probe
2. Vestibular depth (the distance between the coronal margin of the attached gingiva and the greatest concavity of the mucobuccal fold below) measured at 6 months and 12 months after surgical procedure with a CP15 periodontal probe
3. Keratinized tissue increase (measuring one point in each tooth) measured at 6 months and 12 months after surgical procedure with a CP15 periodontal probe

Overall trial start date

05/01/2016

Overall trial end date

21/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Presence of at least 2 adjacent recession class III
2. Periodontal pocket depth <5 mm
3. No bleeding on probing
4. Bone loss >2 mm
5. <2 mm keratinized tissue
6. No intra-bony defects >2 mm
7. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

Recession class I or II

Recruitment start date

01/03/2016

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Spain

Trial participating centre

PerioCentrum Research
Alameda Urquijo Street n2 7ºfloor
Bilbao
48008
Spain

Sponsor information

Organisation

Periocentrum Research Bilbao

Sponsor details

Alameda Urquijo Street n2 7ºfloor
Bilbao
48008
Spain

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Periocentrum Research Bilbao

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-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

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review.