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.
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.
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.
- Conditions
- Gingival Recession
- 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 group | Role | What they receive |
|---|---|---|
| CTG+CAF | Active comparator | The surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap Receives: Procedure: CTG+CAF |
| peCTG+CAF | Experimental | A 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.
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)
Recession Width in mm
The width of the exposed root will be measured using a UNC-15 periodontal probe
Measured: 6 months
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
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
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
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
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.
- First posted31 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar El-Zanaty, Cairo University
- Investigators
- Manar T Elzanaty, Master, Principal investigator, Cairo University
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 22639845Chambrone 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 25644302Kumar 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 24174767Cairo 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03416673
- Acronym / sponsor ID
- peCTG-MC3
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 31 Jan 2018 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTG+CAF | Active comparator | Procedure: CTG+CAFThe surgical procedure will include a connective tissue graft harvested from the palate and used under a coronally advanced flap |
| peCTG+CAF | Experimental | Procedure: peCTG+CAFA papillary extended connective tissue graft reshaped after harvested from the palate will be used under a coronally advanced flap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| peCTG+CAFA connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed | Procedure or surgery | peCTG+CAF |
| CTG+CAFA connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap | Procedure or surgery | CTG+CAF |
Primary outcome
Recession Depth in mm
Time frame: 6 months
The vertical amount of root exposed will be measured using a UNC-15 periodontal probe
6 secondary outcomes
Recession Width in mm
Time frame: 6 months
Probing depth in mm
Time frame: 6 months
Gingival thickness in mm
Time frame: 6 months
Width of keratinized gingiva in mm
Time frame: 6 months
Root coverage esthetic score (Cairo et al. 2009)
Time frame: 6 months
Patient satisfaction (Kim et al. 2014)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Background: PubMed 22639845Cairo 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.
- Background: PubMed 25644302Chambrone 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.
- Background: PubMed 24174767Kumar 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.
- Background: PubMed 19335093Cairo 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.
- Individual participant dataSharing planned: Undecided
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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.
Manar T Elzanaty, Master principal investigator
Cairo University
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.