Gingival ThicknessNCT04632693
Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession
A study testing CAF with SCTG and Vitamin C injection and CAF with SCTG alone in people with Gingival Thickness, run by Cairo University at 1 site in Egypt.
Trial summary
Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Thickness
- What is being tested?
- CAF with SCTG and Vitamin C injection and CAF with SCTG alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to Jun 2021
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Buccal recession defects classified as Cairo RT1.
- Presence of identifiable CEJ (Zucchelli et al., 2010).
- Clinical indication and/or patient request for recession coverage.
- O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).
Who cannot join
- Cairo RT2 or RT3 recession defects.
- Pregnant females.
- Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
- Teeth with cervical restorations, abrasion and malalignment.
- Presence of systemic disease that would affect wound healing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine - CU
Cairo
Andrew Albert A. Zaki, MSc, 01274805636, andrew.anwar@dentistry.cu.edu.eg
About this study
Official title: Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession
Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.
Read the detailed description
Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.
- Conditions
- Gingival Thickness
- Being tested
- CAF with SCTG and Vitamin C injection, CAF with SCTG alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAF with SCTG and Vitamin C injectionProcedure or surgery
Injection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession.
CAF with SCTG aloneProcedure or surgery
Coronally advanced flap with subepithelial connective tissue graft.
| Study group | Role | What they receive |
|---|---|---|
| CAF with SCTG and vitamin C | Experimental | Coronally advanced flap with subepithelial connective tissue graft and vitamin C. Receives: Procedure: CAF with SCTG and Vitamin C injection |
| CAF with SCTG | Active comparator | Coronally advanced flap with subepithelial connective tissue graft. Receives: Procedure: CAF with SCTG alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ginigval thickness
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.
Measured: 6 months
Secondary outcomes (10)
Root Coverage Esthetic Score
A system proposed for evaluating esthetic outcomes of root coverage procedures. The RES system evaluated five variables at 6-months after surgery: the level of the gingival margin, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color.
Measured: 6 months
Early Healing Index
A system proposed for the clinical assessment of the early wound events by using a differentiated early wound healing index (EHI) (Wachtel et al., 2003).
Measured: 6 months
Gingival Recession Depth (RD)
Measured from the CEJ to the most apical extension of the gingival margin.
Measured: 6 months
Gingival Recession Width (RW)
Measured horizontally between the borders of the recession at the level of CEJ.
Measured: 6 months
Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Measured: 6 months
Probing Depth (PD)
Measured from the gingival margin to the bottom of the gingival sulcus.
Measured: 6 months
Clinical Attachment Level (CAL)
Measured from the CEJ to the bottom of the gingival sulcus.
Measured: 6 months
Height of Keratinized Tissue (KTH)
Measured as the distance between the gingival margin and the mucogingival junction (MGJ).
All measurements will be performed by means of the UNC periodontal probe and will be rounded up to the nearest millimeter.
Measured: 6 months
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.
Measured: 2 weeks
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
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 posted17 Nov 2020
- Study start1 Sep 2020
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival ThicknessStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Albert Anwar Zaki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632693
- Sponsor's protocol ID
- 3-6-20
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession
- ClinicalTrials.gov ID
- NCT04632693
- Acronym / sponsor ID
- 3-6-20
- Conditions
- Gingival Thickness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 17 Nov 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.
Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.
Detailed description
Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF with SCTG and vitamin C | Experimental | Procedure: CAF with SCTG and Vitamin C injectionCoronally advanced flap with subepithelial connective tissue graft and vitamin C. |
| CAF with SCTG | Active comparator | Procedure: CAF with SCTG aloneCoronally advanced flap with subepithelial connective tissue graft. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 18 years or older.
- Periodontally and systemically healthy.
- Buccal recession defects classified as Cairo RT1.
- Presence of identifiable CEJ (Zucchelli et al., 2010).
- Clinical indication and/or patient request for recession coverage.
Key exclusion criteria (7 listed)
- Cairo RT2 or RT3 recession defects.
- Pregnant females.
- Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
- Handicapped and mentally retarded patients.
- Patients undergoing radiotherapy.
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 |
|---|---|---|
| CAF with SCTG and Vitamin C injectionInjection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession. | Procedure or surgery | CAF with SCTG and vitamin C |
| CAF with SCTG aloneCoronally advanced flap with subepithelial connective tissue graft. | Procedure or surgery | CAF with SCTG |
Primary outcome
Ginigval thickness
Time frame: 6 months
Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.
10 secondary outcomes
Root Coverage Esthetic Score
Time frame: 6 months
Early Healing Index
Time frame: 6 months
Gingival Recession Depth (RD)
Time frame: 6 months
Gingival Recession Width (RW)
Time frame: 6 months
Percentage of root coverage
Time frame: 6 months
Probing Depth (PD)
Time frame: 6 months
Clinical Attachment Level (CAL)
Time frame: 6 months
Height of Keratinized Tissue (KTH)
Time frame: 6 months
Post-Operative Pain
Time frame: 2 weeks
Post-Surgical Patient Satisfaction
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 17 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Gingival Thickness
Not yet recruiting
Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.
Thin Gingival Phenotype
Not yet recruitingPhase 2/3
Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft Tissue
Peri-implant Mucosa Thickness
RecruitingObservational study
Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
Gingival Biotype, Gingival Phenotype
Active, not recruiting
V-Reverse Suture Technique Compared to Traditional Anchored Sling Suture in Treating Multiple Gingival Recession
Gingival Recession, Mucogingival Surgery
Not yet recruitingPhase 1/2
Adding Effect of Cross-linked Hyaluronic Acid to Microneedling After Coronally Advanced Flap in Isolated RT1 Recession
Single RT1 Gingival Recession With no Loss of Interproximal Attachment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAF with SCTG and Vitamin C injection and CAF with SCTG alone in people with Gingival Thickness, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 7 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 17 Nov 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Albert A. Zaki, MSc (01274805636, andrew.anwar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ginigval thickness (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2020.