Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802473
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2021-03-12
Brief Title:
Flap Thickness Upon Root Coverage With the Use of Acellular Dermal Matrix
Sponsor:
Universitat Internacional de Catalunya
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
Influence of Flap Thickness Upon Root Coverage With the Use of Acellular Dermal Matrix a Prospective Case Series
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OrACell has been tested as a barrier in bone regenerative procedures showing promising results in new bone formation after socket preservation but no data is available on root coverage procedures Moreover it has been suggested that keratinized tissue width KTW 2mm and gingival thickness GT 12 mm at 6 months of the surgical procedures are two important predictors for long term stability of gingival margin Therefore it was hypothesized that soft tissue thickness and keratinized tissue width may influence the percentage of root coverage By means of a prospective case series 12 patients in total the aim is to study the performance of the OrACell dermal matrix in the treatment of multiple and adjacent gingival recessions determining the amount of complete root coverage obtained at 6 months of follow-up At the same time it is intended to evaluate the effect of initial gingival thickness by means of digital scanning upon the success of root coverage procedure with OrACell
Detailed Description:
Background
Gingival recession is a lesion characterized by clinical attachment loss of the periodontal apparatus to the root surface of the tooth resulting in an apical migration of the gingival margin that occasionally generates esthetic problems hypersensitivity and difficulty in maintaining proper hygiene To correct this the additional use of connective tissue grafts in root coverage procedures has reported highly predictable results Over time different substitutes such as acellular dermal matrix ADM xenografts XEN have been suggested to reduce patient morbidity by avoiding the donor site Recently an acellular dermal allograft known as OrAcell has shown good results in terms of soft tissue regeneration and guided bonetissue regeneration
Objectives
Overall objective The objective of this prospective case series is to evaluate the influence of initial soft tissue thickness STT upon the success of a surgical root coverage procedure Specific objective To assess the statistical correlation of keratinized tissue width KTW and VD on the outcome RC of the TUN plus acellular dermal matrix ADM
Hypothesis
Null hypothesis H01 STT is not a predictor for root coverage procedures and does not influence the percentage of root coverage
H02 KTW is not a predictor for root coverage procedures and does not influence the percentage of root coverage
H03 VD is not a predictor for root coverage procedures and does not influence the percentage of root coverage
Alternative hypothesis
H11 STT is a predictor for root coverage procedures and detrimentally influences the percentage of root coverage
H12 KTW is a predictor for root coverage procedures and a low VD detrimentally influences the percentage of root coverage
H13 VD is a predictor for root coverage procedures and detrimentally influences the percentage of root coverage
Material and methods
Study design This is a prospective case series with a 6-month follow-up
Setting of the study The study will be performed at a private practice setting associated to the Universitat Internacional de Catalunya UIC Subjects will be selected on a consecutive basis among individuals referred to a specialist periodontists private practice
Study population
Subjects affected by at least one GR in single rooted teeth will be included in the study They will be selected on a consecutive basis among individuals referred to the authors private practice The study protocol and informed consent will be reviewed by the Ethical Committee of the Universitat Internacional de Catalunya Barcelona Spain and will be conducted the Helsinki Declaration 1975 as revised in 2013
Surgical treatment
All surgeries will be performed by expert periodontists GB In brief description TUNADM treatment will be performed by starting initial sulcular incisions tunneling knives will be used to elevate the buccal gingiva by means of a full-thickness flap elevation Flap preparation will be extended beyond the MGJ The periosteum will be cut and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the teeth The exposed root surfaces will be treated with pre-conditioning EDTA Straumann PrefGel for 2 minutes ADM OrACELL LifeNet Helth Virginia Beach VA USA of 125-175mm in thickness will be cut to the exact size of the defect and will be inserted into the tunnel and subsequently covered advancing the flap by means of sling sutures to stabilize the flap in a coronal position 6-0 Polypropylene Prolene Ethicon Johnson and Johnson New Brunswick NJ USA
Patients will be instructed to avoid any mechanical trauma or toothbrushing in the surgical sites for 2 weeks Analgesic medication ibuprofen will be prescribed as required and patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks Sutures will be removed after 14 days Two weeks after surgery patients will resume mechanical tooth cleaning with a soft toothbrush Patients will be recalled at 1 3 and 6 months for professional oral hygiene procedures
Post-surgical instructions and infection control
Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks Analgesic medication ibuprofen will be prescribed as required and patients will be instructed to rinse with Chlorhexidine 012 two times per day for 2 weeks Sutures will be removed after 14 days Two weeks after surgery patients will resume mechanical tooth cleaning with a soft toothbrush Patients will be recalled at 1 3 and 6 months for professional oral hygiene procedures
Blindness The clinical examiner RP will be unaware of digital measurements performed by a second researcher JV and vice versa
Blindness will be maintained strictly confidential by the investigators
Data collection
A guidebook will be prepared to systematize the procedures for sample and data collection The data will be later transferred to a computerized database Epidata Odense Denmark Europe
A Sociodemographic data An interview will be conducted during the pre-surgical visit to obtain information regarding age sex medical history use of medication exposure to tobacco pregnancy and previous periodontal surgeries
B Clinical measurements The following clinical measurements will be performed by blinded examiners using a periodontal probe PCP UNC 15 Hu-Friedy Chicago IL USA Probing Depth PD and keratinized tissue width KTW KTW will be measured at the most apical point in the GM to the mucogingival junction at the mid-buccal site to the nearest millimeter KTT will be measured 15mm and 3mm apical to the GM using an injection needle perpendicular to the tissues surface and a silicon stop over the gingival surface and fixed with a cyanoacrylic adhesive
C Digital measurements A digital scan of the arch with the teeth to be treated will be performed with an optical 3D measurement system 3Shape Trios Copenhagen Denmark creating Surface Tessellation Language STL files The acquired data will be transferred into a digital imaging software 3Shape Trios Erlangen Germany Baseline and corresponding follow-up scans of each clinical case will be then virtually superimposed and matched into one common coordinate system Geomagic 3D Systems Research Triangle Park NC USA using the tool Control X By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points pre-operative and post-operative this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner JV
The following measurements will be taken
RD will be measured from CEJ to the GM in a cross section at the central buccal site 24
Change in KTT will be measured as mean thickness of the marginal soft tissues by superimposing STL files at 15mm and 3mm apical to the GM
All clinical measurements and volumetric evaluations of the soft will be performed at baseline 3 months and at 6 months after surgery
D Patient reported outcomes measures PROMS
Patient reported outcomes in terms of aesthetics and morbidity during treatment will be evaluated as follows
A total of seven questions will be evaluated at suture removal using a visual analogue scale VAS score VAS 0-100 100 reflecting the highest morbidity Pain during surgery pain and swelling in the weeks following the mucogingival surgery until suture removal will be assessed for the recipient site Patients will be further asked about their willingness to repeat the treatment In addition the use of pain medication and the number of days pain medication taken will be reported at the same time- point
Moreover patients esthetic satisfaction will be recorded by means of a visual analog scale VAS with a score between 0 poor and 10 excellent
Withdrawal of consent The Patient Information Sheet will clearly state that the patient can withdraw from the study at any time without prejudice or explanation Such withdrawal will be documented in the medical record file
Sample size calculation The study is powered based on an objective of this study the correlation between the outcome of root coverage MRC and an anatomical independent continuous variable the STT A previous study 25 reported a statistically significant negative correlation between root prominence and linear root coverage measurements r -08 Using this data and accepting an alpha risk of 5 a beta risk of 10 in a one-sided test and assuming a 10 of dropout a minimum of 12 patientssites were determined as necessary to conduct the research
Due to the methodological discrepancies regarding the surgical approach and the primary with the aforementioned article 25 an interim analysis will be performed to reassess statistical power and determine the need of increasing or not the sample size
Statistical analysis
Descriptive statistics will be calculated for continuous and categorical variables using means and standard deviations or frequencies and percentages respectively
Data distribution will be assessed by means of Shapiro Wilk test Differences between baseline 3 and 6 months post-operatively quantitative variables will be analyzed using a generalized lineal model or Friedman test according to the distribution of the variables With regard to qualitative variables McNemar test will be performed to compare differences between groups
The association or correlation between CRC and of CRC and STT will be evaluated using he Pearson or Spearman correlation coefficient
MRC will be calculated using the following formula preoperative RD - postoperative RDpreoperative RD x 100 The RC will be transformed to a binary variable the presence of 100 of complete RC CRC At each timepoint logistic multilevel models considering both patient and tooth levels will be performed to investigate factors influencing the CRC Baseline variables will be included in the models as explicative variables
The level of statistical significance will be set at p 05 Analysis will be performed by the use of SPSS 220 software package IBM SPSS SPSS Inc Chicago IL USA
Gingival recession is a lesion characterized by clinical attachment loss of the periodontal apparatus to the root surface of the tooth resulting in an apical migration of the gingival margin that occasionally generates esthetic problems hypersensitivity and difficulty in maintaining proper hygiene To correct this the additional use of connective tissue grafts in root coverage procedures has reported highly predictable results Over time different substitutes such as acellular dermal matrix ADM xenografts XEN have been suggested to reduce patient morbidity by avoiding the donor site Recently an acellular dermal allograft known as OrAcell has shown good results in terms of soft tissue regeneration and guided bonetissue regeneration
Objectives
Overall objective The objective of this prospective case series is to evaluate the influence of initial soft tissue thickness STT upon the success of a surgical root coverage procedure Specific objective To assess the statistical correlation of keratinized tissue width KTW and VD on the outcome RC of the TUN plus acellular dermal matrix ADM
Hypothesis
Null hypothesis H01 STT is not a predictor for root coverage procedures and does not influence the percentage of root coverage
H02 KTW is not a predictor for root coverage procedures and does not influence the percentage of root coverage
H03 VD is not a predictor for root coverage procedures and does not influence the percentage of root coverage
Alternative hypothesis
H11 STT is a predictor for root coverage procedures and detrimentally influences the percentage of root coverage
H12 KTW is a predictor for root coverage procedures and a low VD detrimentally influences the percentage of root coverage
H13 VD is a predictor for root coverage procedures and detrimentally influences the percentage of root coverage
Material and methods
Study design This is a prospective case series with a 6-month follow-up
Setting of the study The study will be performed at a private practice setting associated to the Universitat Internacional de Catalunya UIC Subjects will be selected on a consecutive basis among individuals referred to a specialist periodontists private practice
Study population
Subjects affected by at least one GR in single rooted teeth will be included in the study They will be selected on a consecutive basis among individuals referred to the authors private practice The study protocol and informed consent will be reviewed by the Ethical Committee of the Universitat Internacional de Catalunya Barcelona Spain and will be conducted the Helsinki Declaration 1975 as revised in 2013
Surgical treatment
All surgeries will be performed by expert periodontists GB In brief description TUNADM treatment will be performed by starting initial sulcular incisions tunneling knives will be used to elevate the buccal gingiva by means of a full-thickness flap elevation Flap preparation will be extended beyond the MGJ The periosteum will be cut and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the teeth The exposed root surfaces will be treated with pre-conditioning EDTA Straumann PrefGel for 2 minutes ADM OrACELL LifeNet Helth Virginia Beach VA USA of 125-175mm in thickness will be cut to the exact size of the defect and will be inserted into the tunnel and subsequently covered advancing the flap by means of sling sutures to stabilize the flap in a coronal position 6-0 Polypropylene Prolene Ethicon Johnson and Johnson New Brunswick NJ USA
Patients will be instructed to avoid any mechanical trauma or toothbrushing in the surgical sites for 2 weeks Analgesic medication ibuprofen will be prescribed as required and patients will be instructed to rinse with Chlorhexidine three times per day for 2 weeks Sutures will be removed after 14 days Two weeks after surgery patients will resume mechanical tooth cleaning with a soft toothbrush Patients will be recalled at 1 3 and 6 months for professional oral hygiene procedures
Post-surgical instructions and infection control
Patients will be instructed to avoid any mechanical trauma or tooth brushing in the surgical sites for 2 weeks Analgesic medication ibuprofen will be prescribed as required and patients will be instructed to rinse with Chlorhexidine 012 two times per day for 2 weeks Sutures will be removed after 14 days Two weeks after surgery patients will resume mechanical tooth cleaning with a soft toothbrush Patients will be recalled at 1 3 and 6 months for professional oral hygiene procedures
Blindness The clinical examiner RP will be unaware of digital measurements performed by a second researcher JV and vice versa
Blindness will be maintained strictly confidential by the investigators
Data collection
A guidebook will be prepared to systematize the procedures for sample and data collection The data will be later transferred to a computerized database Epidata Odense Denmark Europe
A Sociodemographic data An interview will be conducted during the pre-surgical visit to obtain information regarding age sex medical history use of medication exposure to tobacco pregnancy and previous periodontal surgeries
B Clinical measurements The following clinical measurements will be performed by blinded examiners using a periodontal probe PCP UNC 15 Hu-Friedy Chicago IL USA Probing Depth PD and keratinized tissue width KTW KTW will be measured at the most apical point in the GM to the mucogingival junction at the mid-buccal site to the nearest millimeter KTT will be measured 15mm and 3mm apical to the GM using an injection needle perpendicular to the tissues surface and a silicon stop over the gingival surface and fixed with a cyanoacrylic adhesive
C Digital measurements A digital scan of the arch with the teeth to be treated will be performed with an optical 3D measurement system 3Shape Trios Copenhagen Denmark creating Surface Tessellation Language STL files The acquired data will be transferred into a digital imaging software 3Shape Trios Erlangen Germany Baseline and corresponding follow-up scans of each clinical case will be then virtually superimposed and matched into one common coordinate system Geomagic 3D Systems Research Triangle Park NC USA using the tool Control X By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points pre-operative and post-operative this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner JV
The following measurements will be taken
RD will be measured from CEJ to the GM in a cross section at the central buccal site 24
Change in KTT will be measured as mean thickness of the marginal soft tissues by superimposing STL files at 15mm and 3mm apical to the GM
All clinical measurements and volumetric evaluations of the soft will be performed at baseline 3 months and at 6 months after surgery
D Patient reported outcomes measures PROMS
Patient reported outcomes in terms of aesthetics and morbidity during treatment will be evaluated as follows
A total of seven questions will be evaluated at suture removal using a visual analogue scale VAS score VAS 0-100 100 reflecting the highest morbidity Pain during surgery pain and swelling in the weeks following the mucogingival surgery until suture removal will be assessed for the recipient site Patients will be further asked about their willingness to repeat the treatment In addition the use of pain medication and the number of days pain medication taken will be reported at the same time- point
Moreover patients esthetic satisfaction will be recorded by means of a visual analog scale VAS with a score between 0 poor and 10 excellent
Withdrawal of consent The Patient Information Sheet will clearly state that the patient can withdraw from the study at any time without prejudice or explanation Such withdrawal will be documented in the medical record file
Sample size calculation The study is powered based on an objective of this study the correlation between the outcome of root coverage MRC and an anatomical independent continuous variable the STT A previous study 25 reported a statistically significant negative correlation between root prominence and linear root coverage measurements r -08 Using this data and accepting an alpha risk of 5 a beta risk of 10 in a one-sided test and assuming a 10 of dropout a minimum of 12 patientssites were determined as necessary to conduct the research
Due to the methodological discrepancies regarding the surgical approach and the primary with the aforementioned article 25 an interim analysis will be performed to reassess statistical power and determine the need of increasing or not the sample size
Statistical analysis
Descriptive statistics will be calculated for continuous and categorical variables using means and standard deviations or frequencies and percentages respectively
Data distribution will be assessed by means of Shapiro Wilk test Differences between baseline 3 and 6 months post-operatively quantitative variables will be analyzed using a generalized lineal model or Friedman test according to the distribution of the variables With regard to qualitative variables McNemar test will be performed to compare differences between groups
The association or correlation between CRC and of CRC and STT will be evaluated using he Pearson or Spearman correlation coefficient
MRC will be calculated using the following formula preoperative RD - postoperative RDpreoperative RD x 100 The RC will be transformed to a binary variable the presence of 100 of complete RC CRC At each timepoint logistic multilevel models considering both patient and tooth levels will be performed to investigate factors influencing the CRC Baseline variables will be included in the models as explicative variables
The level of statistical significance will be set at p 05 Analysis will be performed by the use of SPSS 220 software package IBM SPSS SPSS Inc Chicago IL USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None