AzTrials
AzTrials

Gingival RecessionNCT03416673

Effectiveness of the Papillary Extended Connective Tissue Graft in Miller Class III Gingival Recession

A study testing peCTG+CAF and CTG+CAF in people with Gingival Recession, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

34 patients with Miller class III will be included in this study, where 17 participants will be treated with connective tissue graft with coronally advanced flap (control group) and 17 participants will be treated with a papillary extended connective tissue graft with coronally advanced flap (test group) and followed… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession
What is being tested?
peCTG+CAF and CTG+CAF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
Feb 2018to Feb 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 years or older. Periodontally and systemically healthy. Buccal recession defects classified as Miller class III. Presence of identifiable CEJ (Zucchelli et al., 2010). Clinical indication and/or patient demand for recession coverage. O'Leary index less than 20% (O'Leary et al., 1972).

Who cannot join

  • Miller class I, II or IV recession defects. Pregnant females. Smokers as smoking is contraindicated at any plastic periodontal surgery (Khuller, 2009).
  • Handicapped and mentally retarded patients. Teeth with cervical restorations or abrasion. Taking medication known to affect periodontal healing. Previous periodontal surgery on the involved site.

Trial locations and contacts

No sites are listed yet.

Manar T Elzanaty, Master contact

+201001775660

manar.elzanaty@dentistry.cu.edu.eg

Noha A Ghallab, Doctorate contact

+201005263365

noha.ghallab@dentistry.cu.edu.eg

About this study

Official title: Clinical Effectiveness of Coronally Advanced Flap With Papillary Extended Connective Tissue Graft Versus Connective Tissue Graft in Miller Class III Recession: A Randomized Clinical Trial

34 patients with Miller class III will be included in this study, where 17 participants will be treated with connective tissue graft with coronally advanced flap (control group) and 17 participants will be treated with a papillary extended connective tissue graft with coronally advanced flap (test group) and followed up for 6 months.

Read the detailed description

Each patient will be inspected to check if the patient fits for the eligibility criteria. If the patient meets the standards, phase I therapy for periodontal plastic procedures will be performed including thorough supragingival scaling and subgingival debridement. Preservation of appropriate plaque control (both mechanical and chemical) by the patient will be executed as well.

Surgical procedures:

It will be done by the principal investigator.

CTG harvesting:

A measurement of the approximate length and width of the graft required will be taken. A CTG will be harvested from the palate using single incision technique as described by Kumar et al. (2013) as follows:

The graft will be harvested from the palate between the distal aspect of the canine and the mid-palatal region of the first molar.

  • A template will be placed on the palate to mark the extent of the graft, after local anesthesia is administered.
  • A single incision 2 mm apical to the gingival margin will be done. The blade will be placed approximately parallel to the long axis of the palate to provide the first incision.
  • The partial thickness flap will be raised as far apically as required, in accordance with the graft size, as measured by the template, using a periosteal elevator. The thickness of the flap will be sufficient to reduce the probability of tearing and sloughing.
  • Following this, the blade will be angled perpendicular to the palate through the same incision and continued to the bone. After the incision to the bone, the connective tissue will be elevated from the underlying bone with a periosteal elevator. Then two vertical incisions on the mesial and distal ends of the graft and one horizontal medial incision will be performed (under the partial thickness flap), to release it from the surrounding tissue.
  • The graft will be harvested through that single incision and pressure applied to the donor site with gauze soaked in saline after the graft was taken. The donor site will be sutured using a 4-0 silk suture.

For the peCTG, the CTG will be furtherly prepared by creating the papillary extensions using a tissue punch, according to the number of teeth with gingival recession.

Surgical protocol:

The surgical area will be prepared and adequately anesthetized using 4% articaine hydrochloride 1/100 000 epinephrine by giving block and/or infiltration anesthesia. After attaining adequate anesthesia, at a point apical to the papilla tip, vertical incisions will be made lateral to the area of recession extending into alveolar mucosa. The alveolar mucosa between the two vertical incisions will then be undermined by sharp dissection with undermining going into the vestibule while remaining parallel with the surface. Then, a sulcular incision will be used to reflect the coronal portion of the flap by sharp dissection close to the periostium until reaching the split thickness incision

previously made in alveolar mucosa. A gingivoplasty of each papilla adjacent to the recession will then be performed. This excision will not reduce the height of the papilla, but is designed to create a bleeding surface which will serve as a bed for the connective tissue graft (Allen and Miller, 1989).

A triangular flap will be elevated by a sharp dissection with no. 15c scalpel blade to raise a combined full-partial thickness flap to the level of the MGJ.

In the test group (group A), peCTG will be placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ, and the papillary extensions are inserted interdentally covering the de-epithelized papillae, while in the control group (group B), CTG will be also placed over the recession defect leaving the coronal margin of the graft at the level of the CEJ. In both groups, all graft material will be sutured to the periosteum using 6-0 resorbable suture. Finally the flaps will be positioned coronally to the CEJ without tension using 6-0 polyglycolic acid suture material. Hemostasis will be achieved by applying gentle finger pressure for 4 minutes.

Post-surgical protocol:

  • Postoperative oral analgesics (Ibuprofen 600 mg t.d.s) will be prescribed to the patients for the first 3 days then whenever desirable. Systemic antibiotic will be prescribed (Amoxicillin 500mg t.d.s) for 5 days to prevent the infection postsurgical.
  • Patients will be instructed to rinse with 0.12% Chlorhexidine oral rinse twice daily for 2 weeks.
  • Participants will be instructed to avoid excessive muscle tractioning or trauma to the treated areas for the first 3 weeks and will be told not to brush teeth involved in the surgery.
  • After 10-14 days the sutures will be removed.
  • Three weeks post surgically the patients will be instructed to gently brush the operated area with a soft tooth brush using roll technique.
Being tested
peCTG+CAF, CTG+CAF
Medical subject headings
Gingival Recession

What participants receive

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

  • peCTG+CAFProcedure or surgery

    A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed

  • CTG+CAFProcedure or surgery

    A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap

Study groups in NCT03416673
Study groupRoleWhat they receive
CTG+CAFActive comparatorThe surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap
Receives: Procedure: CTG+CAF
peCTG+CAFExperimentalA papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap
Receives: Procedure: peCTG+CAF

What is being measured

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

  1. Recession Depth in mm

    The vertical amount of root exposed will be measured using a UNC-15 periodontal probe

    Measured: 6 months

Secondary outcomes (6)
  1. Recession Width in mm

    The width of the exposed root will be measured using a UNC-15 periodontal probe

    Measured: 6 months

  2. Probing depth in mm

    Measured from the gingival margin to the base of the sulcus will be measured using a UNC-15 periodontal probe

    Measured: 6 months

  3. Gingival thickness in mm

    the thickness of the gingival tissues will be measured by piercing the gingiva till touching bone with a #15 endodontic reamer under anethesia

    Measured: 6 months

  4. Width of keratinized gingiva in mm

    from the gingival margin to the mucogingival junction will be measured using a UNC-15 periodontal probe

    Measured: 6 months

  5. Root coverage esthetic score (Cairo et al. 2009)

    evaluation of the esthetic outcomes of root coverage procedures according to Cairo et al. 2009 Root Coverage Esthetic Score

    Measured: 6 months

  6. Patient satisfaction (Kim et al. 2014)

    measuring the degree of satisfaction of the patients according to Kim et al. 2014 questionnaire

    Measured: 6 months

Timeline

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

  1. First posted31 Jan 2018
  2. Study startFeb 2018 (estimated)
  3. Primary completionAug 2018 (estimated)
  4. Study completionFeb 2019 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03416673
Sponsor's protocol ID
peCTG-MC3
Status last verified
Jan 2018
First submitted
18 Jan 2018
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.

    PubMed 22639845
  • Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.

    PubMed 25644302
  • Kumar A, Sood V, Masamatti SS, Triveni MG, Mehta DS, Khatri M, Agarwal V. Modified single incision technique to harvest subepithelial connective tissue graft. J Indian Soc Periodontol. 2013 Sep;17(5):676-80. doi: 10.4103/0972-124X.119294.

    PubMed 24174767
  • Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

    PubMed 19335093

Questions about this trial

What is this clinical trial studying?

A study testing peCTG+CAF and CTG+CAF in people with Gingival Recession, run by Cairo University.

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 1 inclusion and 2 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Manar T Elzanaty, Master (+201001775660, manar.elzanaty@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recession Depth in mm (time frame: 6 months). 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 NCT03416673, which also lists 4 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 31 Jan 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in