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Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects

Primary Purpose

Recession, Gingival

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
De-epithelialized connective tissue graft wall
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession, Gingival

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Smokers.
  • Pregnancy and lactation.
  • Stage 4 Grade C periodontitis.

Sites / Locations

  • Faculty of dentistry Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

De-epithelialized connective tissue graft wall

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Gingival Recession Width
Horizontal distance will be measured from one border of the recession to another in mesio-distal direction at CEJ level
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
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
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
Clinical Attachment Level
Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.
Width of the Keratinized Tissue
Measured from the gingival margin to the muco-gingival junction using William's periodontal probe.
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
Post-Operative patient's Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
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
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

Full Information

First Posted
August 11, 2020
Last Updated
August 29, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04514055
Brief Title
Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
De-epithelialized connective tissue graft wall
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
De-epithelialized connective tissue graft wall
Intervention Description
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
Primary Outcome Measure Information:
Title
Gingival recession depth
Description
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.
Time Frame
Changes at 3 and 6 months post-operative
Secondary Outcome Measure Information:
Title
Radiographic bone fill
Description
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
Time Frame
At 6 months post-operative
Title
Gingival Recession Width
Description
Horizontal distance will be measured from one border of the recession to another in mesio-distal direction at CEJ level
Time Frame
Changes at 3 and 6 months post-operative
Title
Percentage of Root Coverage
Description
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
Time Frame
Changes at 3 and 6 months post-operative
Title
Gingival Thickness
Description
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
Time Frame
Changes at 3 and 6 months post-operative
Title
Probing Depth
Description
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
Time Frame
Changes at 3 and 6 months post-operative
Title
Clinical Attachment Level
Description
Measured from the CEJ to the bottom of the gingival sulcus using William's periodontal probe.
Time Frame
At 3 and 6 months post-operative
Title
Width of the Keratinized Tissue
Description
Measured from the gingival margin to the muco-gingival junction using William's periodontal probe.
Time Frame
At 3 and 6 months post-operative
Title
Post-Operative Pain
Description
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'the most painful) measured daily for the first 2 weeks postoperatively
Time Frame
At 7 and 14 days post-operative
Title
Post-Operative patient's Satisfaction
Description
A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
Time Frame
At 6 months post-operative
Title
Bleeding on Probing
Description
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
Time Frame
At 6 months post-operative
Title
Plaque Index
Description
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
Time Frame
At 6 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Smokers. Pregnancy and lactation. Stage 4 Grade C periodontitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Bendary
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry Cairo University
City
Cairo
ZIP/Postal Code
11552
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study protocol, informed consent, clinical study report
IPD Sharing Time Frame
After completion of the study
IPD Sharing Access Criteria
ClinicalTrials.gov
IPD Sharing URL
http://ClinicalTrials.gov

Learn more about this trial

Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects

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