Recession, GingivalNCT04514055
Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects
A study testing De-epithelialized connective tissue graft wall in people with Recession, Gingival, run by Cairo University at 1 site in Egypt.
Trial summary
Recession presents a day to day challenge due to the high esthetic demand of the patients. The prevalence, extent, and severity of recession associated with intra-bony defects due to periodontitis increases with age rendering the success of the root coverage procedures questionable due to loss of interdental papillary… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Recession, Gingival
- What is being tested?
- De-epithelialized connective tissue graft wall
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Jun 2022
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Teeth with buccal RT2 and RT3 recession associated with an intra-bony defect on single rooted teeth.
- Single and multiple recessions.
- Full mouth plaque score (FMPS )<20% at baseline.
- Full mouth bleeding score (FMBS )<10% at baseline.
- Systemically healthy.
- Cooperative patients.
Who cannot join
- Smokers.
- Pregnancy and lactation.
- Stage 4 Grade C periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a De-epithelialized Free Gingival Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects: A Case Series
Recession presents a day to day challenge due to the high esthetic demand of the patients. The prevalence, extent, and severity of recession associated with intra-bony defects due to periodontitis increases with age rendering the success of the root coverage procedures questionable due to loss of interdental papillary support. .
Therefore, connective tissue graft wall technique in cases of Cairo's RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill.
Read the detailed description
Recession is usually treated by an array of mucogingival surgical techniques. The choice of the procedure depends on the morphology of the recession defect. Full root coverage in RT2 and RT3 gingival recession defects cannot always be predictably achieved due to the presence of bone loss. Improvement is further complicated when these recessions are associated with intra-bony defects as mucogingival surgical techniques are not designed to treat intra-bony defects. The preferred surgical modality for treatment of intrabony defects is guided tissue regeneration. However when considering recession defects, the amount of root coverage achieved by GTR may be limited with less results achieved.
Most of the root coverage procedures have proven to be successful, however, when recession is associated with intrabony defect especially in cases of low height and thickness of keratinized tissue and GTR is performed, the treatment results were unpredictable and it was found that the recession might increase post-surgically, so the procedure might offer a limited benefit.
Therefore, the technique introduced by Zucchelli et al. in 2014 in cases of RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill. A simplified papilla preservation technique was performed on the defect site, a de-epithelialized free gingival graft was used to treat the gingival recession present and intrabony defects because it acted as a membrane, creating a buccal wall to the intra-bony defect from one side and on the palatal aspect since no flap elevation was done. The palatal connective tissue acted as a palatal wall preventing gingival epithelium and connective tissue from contacting the space created allowing both improved root coverage and bone fill. He reported interproximal probing depth reduction, clinical attachment gain, improvement in the papilla covering the intrabony defect regarding the gingival thickness and root coverage and complete bone fill was shown radiographically in 1 year.
This technique needs more investigations, but it seems encouraging to improve regenerative and esthetic parameters in the treatment of deep infrabony defects, in one surgical session.
- Conditions
- Recession, Gingival
- Being tested
- De-epithelialized connective tissue graft wall
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-epithelialized connective tissue graft wallProcedure or surgery
A de-epithelialized free gingival connective tissue graft will be used to treat Cairo's recession type 2 and type 3 associated with inta-bony defects
| Study group | Role | What they receive |
|---|---|---|
| De-epithelialized connective tissue graft wall | Experimental | Simplified papilla preservation flap will be applied in the narrow interproximal spaces (≤2 mm), where an oblique incision starting from the gingival margin at the buccal-line angle of the involved tooth reaching the mid-interproximal portion of the papilla under the contact point of the adjacent tooth will be performed using a 15c blade.
A free gingival graft will be obtained from the hard palate and de-epithelized extra-orally.
A Coronally advanced flap will be performed. The de-epithelialized FGG will be sutured coronally using a 6-0 vicryl suture to the anatomical papillae of the two teeth adjacent to the defect and apically to the periosteum left in place apical to the exposed bone.
The flap will be sutured using internal Horizontal mattress suture at the base of the simplified papilla and a vertical mattress suture will be placed in a more coronal position so complete soft tissue closure can be obtained. Receives: Procedure: De-epithelialized connective tissue graft wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival recession depth
Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth.
Measured: Changes at 3 and 6 months post-operative
Secondary outcomes (11)
Radiographic bone fill
The depth of intra-bony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six months to detect the amount of bone fill. Individually customized bite blocks will be created for the patients using alginate impression material and acrylic resin. Parallel-angle technique will be used to obtain standardized radiographs
Measured: At 6 months post-operative
Gingival Recession Width
Horizontal distance will be measured from one border of the recession to another in mesio-distal direction at CEJ level
Measured: Changes at 3 and 6 months post-operative
Percentage of Root Coverage
Percentage of root coverage will be calculated by obtaining the baseline recession depth, postoperative recession depth and will be calculated according to the following formula:
(Baseline RD-6 months RD)/(Baseline RD) ×100
Measured: Changes at 3 and 6 months post-operative
Gingival Thickness
Measured 2 mm apical to the gingival margin with a short needle for 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 resistance is found due to presence of bone. The silicone disc stop on the spreader was placed in tight contact with the external gingival tissue surface. After carefully removing the spreader, penetration depth was measured with William's periodontal probe
Measured: Changes at 3 and 6 months post-operative
Probing Depth
Measured from the gingival margin to the bottom of the gingival sulcus using William's periodontal probe with the probe inserted parallel to the long axis of the tooth
Measured: Changes at 3 and 6 months post-operative
Clinical Attachment Level
Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.
Measured: At 3 and 6 months post-operative
Width of the Keratinized Tissue
Measured from the gingival margin to the muco-gingival junction using William's periodontal probe.
Measured: At 3 and 6 months post-operative
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'the most painful) measured daily for the first 2 weeks postoperatively
Measured: At 7 and 14 days post-operative
Post-Operative patient's Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
Measured: At 6 months post-operative
Bleeding on Probing
BOP score will be assessed as the number of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized periodontal probe with a controlled (∼25 g) force to the bottom of the sulcus at six sites (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth
Measured: At 6 months post-operative
Plaque Index
PI will be assessed using a standardized periodontal probe to agitate the gingival margin and assessing the presence or absence of plaque at the margin. This will be recorded at 4 sites per tooth on all teeth
Measured: At 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Oct 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recession, GingivalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Galal Bendary, Cairo University
- Investigators
- Mariam Bendary, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514055
- Sponsor's protocol ID
- 14422019493595
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2020
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, informed consent, clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a De-epithelialized Free Gingival Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects: A Case Series
- ClinicalTrials.gov ID
- NCT04514055
- Acronym / sponsor ID
- 14422019493595
- Conditions
- Recession, Gingival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 14 Aug 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.
Recession presents a day to day challenge due to the high esthetic demand of the patients. The prevalence, extent, and severity of recession associated with intra-bony defects due to periodontitis increases with age rendering the success of the root coverage procedures questionable due to loss of interdental papillary support. .
Therefore, connective tissue graft wall technique in cases of Cairo's RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill.
Detailed description
Recession is usually treated by an array of mucogingival surgical techniques. The choice of the procedure depends on the morphology of the recession defect. Full root coverage in RT2 and RT3 gingival recession defects cannot always be predictably achieved due to the presence of bone loss. Improvement is further complicated when these recessions are associated with intra-bony defects as mucogingival surgical techniques are not designed to treat intra-bony defects. The preferred surgical modality for treatment of intrabony defects is guided tissue regeneration. However when considering recession defects, the amount of root coverage achieved by GTR may be limited with less results achieved.
Most of the root coverage procedures have proven to be successful, however, when recession is associated with intrabony defect especially in cases of low height and thickness of keratinized tissue and GTR is performed, the treatment results were unpredictable and it was found that the recession might increase post-surgically, so the procedure might offer a limited benefit.
Therefore, the technique introduced by Zucchelli et al. in 2014 in cases of RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill. A simplified papilla preservation technique was performed on the defect site, a de-epithelialized free gingival graft was used to treat the gingival recession present and intrabony defects because it acted as a membrane, creating a buccal wall to the intra-bony defect from one side and on the palatal aspect since no flap elevation was done. The palatal connective tissue acted as a palatal wall preventing gingival epithelium and connective tissue from contacting the space created allowing both improved root coverage and bone fill. He reported interproximal probing depth reduction, clinical attachment gain, improvement in the papilla covering the intrabony defect regarding the gingival thickness and root coverage and complete bone fill was shown radiographically in 1 year.
This technique needs more investigations, but it seems encouraging to improve regenerative and esthetic parameters in the treatment of deep infrabony defects, in one surgical session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| De-epithelialized connective tissue graft wall | Experimental | Procedure: De-epithelialized connective tissue graft wallSimplified papilla preservation flap will be applied in the narrow interproximal spaces (≤2 mm), where an oblique incision starting from the gingival margin at the buccal-line angle of the involved tooth reaching the mid-interproximal portion of the papilla under the contact point of the adjacent tooth will be performed using a 15c blade. A free gingival graft will be obtained from the hard palate and de-epithelized extra-orally. A Coronally advanced flap will be performed. The de-epithelialized FGG will be sutured coronally using a 6-0 vicryl suture to the anatomical papillae of the two teeth adjacent to the defect and apically to the periosteum left in place apical to the exposed bone. The flap will be sutured using internal Horizontal mattress suture at the base of the simplified papilla and a vertical mattress suture will be placed in a more coronal position so complete soft tissue closure can be obtained. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Teeth with buccal RT2 and RT3 recession associated with an intra-bony defect on single rooted teeth.
- Single and multiple recessions.
- Full mouth plaque score (FMPS )<20% at baseline.
- Full mouth bleeding score (FMBS )<10% at baseline.
- Systemically healthy.
Key exclusion criteria (3 listed)
- Smokers.
- Pregnancy and lactation.
- Stage 4 Grade C periodontitis.
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 |
|---|---|---|
| De-epithelialized connective tissue graft wallA de-epithelialized free gingival connective tissue graft will be used to treat Cairo's recession type 2 and type 3 associated with inta-bony defects | Procedure or surgery | De-epithelialized connective tissue graft wall |
Primary outcome
Gingival recession depth
Time frame: Changes at 3 and 6 months post-operative
Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth.
11 secondary outcomes
Radiographic bone fill
Time frame: At 6 months post-operative
Gingival Recession Width
Time frame: Changes at 3 and 6 months post-operative
Percentage of Root Coverage
Time frame: Changes at 3 and 6 months post-operative
Gingival Thickness
Time frame: Changes at 3 and 6 months post-operative
Probing Depth
Time frame: Changes at 3 and 6 months post-operative
Clinical Attachment Level
Time frame: At 3 and 6 months post-operative
Width of the Keratinized Tissue
Time frame: At 3 and 6 months post-operative
Post-Operative Pain
Time frame: At 7 and 14 days post-operative
Post-Operative patient's Satisfaction
Time frame: At 6 months post-operative
Bleeding on Probing
Time frame: At 6 months post-operative
Plaque Index
Time frame: At 6 months post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: Yes. study protocol, informed consent, clinical study report
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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.
Mariam Bendary principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-epithelialized connective tissue graft wall in people with Recession, Gingival, 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 3 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: finished, as of the sponsor's last update on 30 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival recession depth (time frame: Changes at 3 and 6 months post-operative). 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 30 Aug 2022.