Effect of graft size on the success of the envelope technique in singular RT1 recessions in the maxillary anterior and premolar area - a prospective cohort study
Organizational Data
- DRKS-ID:
- DRKS00024772
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2021-07-21
- Last update in DRKS:
- 2024-02-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
ENV_GS
URL of the study
No Entry
Brief summary in lay language
One of the most common consequences of periodontal disease is the receding of the gums (recession). This is often perceived by patients as aesthetically disturbing, is associated with hypersensitivity to heat/cold or can lead to a higher susceptibility to caries on the exposed root surface. If the recession is not located circumferentially around the entire tooth, but isolated on the surface facing the lip, this can be treated with a gum transplant (removal from the palate). The aim of this study is to analyze to what extent the ratio of graft size (area) to the area of the exposed root surface has an influence on the success of the gum transplant after 6, 12, 60 and 120 months. The success is assessed as full root coverage after the respective follow-up period. It is assumed (hypothesis) that the graft removed from the palate must be at least twice as large as the exposed root surface. Only adult, healthy, non-smoking patients who have at least one recession in the area of the maxillary anterior teeth (15-25) (not on neighboring teeth) are eligible as participants.
Brief summary in scientific language
The envelope technique according to Raetzke (1985) has been an established method for covering recessions for many years. In contrast to all the other methods described, with this technique part of the graft removed from the palate remains exposed on the root surface without being covered by the surrounding, local tissue. The aim of this study is to find out to what extent complete coverage of the recession after 6, 12, 60 and 120 months depends on the ratio of the graft size (area) to the root surface. It is assumed as a hypothesis that the transplant must have at least twice the size of the recession surface. Healthy adult patients who have at least one single recession (recession type 1) in the maxillary premolar or anterior region are eligible as study participants.
Health condition or problem studied
- ICD10:
- K05.2 - Acute periodontitis
- ICD10:
- K05.3 - Chronic periodontitis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Recession coverage by means of the envelope technique according to Raetzke (removal of connective tissue grafts from the hard palate and transplantation into a recipient site under local anesthesia in a congruent and undermining shape of the recession; part of the graft remains uncovered); The recession and the transplant are digitally recorded pre- and intra-operatively with an intraoral scanner. After 6, 12, 60 and 120 months, an assessment is made as to whether the root surface was and remained completely covered.
Endpoints
- Primary outcome:
- Complete root coverage (dichotomous): For this purpose, the preoperative intraoral scan is superimposed with the corresponding intraoral scan after 6, 12, 60 and 120 months using analysis software. If the natural enamel-cement junction cannot be identified after the two scans have been superimposed, the root is considered to be completely covered.
- Secondary outcome:
- Ratio from graft and recession area (area ratio, metric): For this purpose, the respective area is determined using analysis software by means of an intraoperative scan of the transplant or a preoperative scan of the recession and the corresponding quotient [transplant area/recession area] is calculated. Absolute (mm) and relative (%) root coverage (metric): For this purpose, the preoperative intraoral scan is superimposed with the corresponding intraoral scan after 6, 12, 60 and 120 months using analysis software. The distance between the lowest point of the gingival margin preoperatively to the lowest point of the gingival margin postoperatively is considered to be absolute root coverage. Relative root coverage is the ratio of absolute root coverage multiplied by 100 to the preoperative depth of recession. Probing depths (mm) and bleeding on probing (BOP; dichotomous): Probing depths are recorded to an accuracy of 0.5 mm, as is the BOP, with a simple periodontal probe at 6 sites per test tooth. The probing depth is defined as the distance from the bottom of the pocket to the lowest point of the gingival margin. If bleeding occurs during one of the probes, this point is rated as BOP positive. Width of the keratinized gingiva (mm, metric): For this purpose, the respective intraoral scan is measured using analysis software from the lowest point of the gingival margin in the course of the tooth axis to the mucogingival junction. Plaque and gingival index (categorical): The plaque index is collected using a periodontal probe at 6 points on the operated tooth. For this purpose, the corresponding 6 sites per tooth are assessed visually using a given coding (Loe, 1967). The gingival index is also surveyed with a periodontal probe at 6 sites on the operated tooth. For this purpose, the corresponding 6 sites per tooth in the area of the gingival margin are carefully smeared with the periodontal probe at a 45 ° angle and then assessed using a given coding (Loe, 1967). Oral Health Impact Profile (OHIP; metric): The information on oral health-related quality of life is recorded using the OHIP-G49 questionnaire. Self-perceived aesthetics (metric): The patient's self-perceived aesthetics are recorded using a visual analog scale.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Zentrum für Zahn-, Mund- und Kieferheilkunde (Carolinum) der J.W.G.-Universität Frankfurt am Main, Poliklinik für Parodontologie Frankfurt a.M.
Recruitment period and number of participants
- Planned study start date:
- 2025-01-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 27
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - written informed consent - non-smokers - no untreated periodontal disease - Plaque and gingival index ≤ 25% (Ainamo and Bay, 1975, O'Leary et al., 1972) - no intake of drugs that affect periodontal tissue/healing (e.g. calcium channel blockers, phenytoins, cyclosporins) - no existing contraindication for periodontal surgery - at least one single RT1 recession (Cortellini and Bissada, 2018) with a clearly identifiable, natural enamel-cement junction (tooth must be unrestored)
Exclusion Criteria
- pregnancy - presence of systemic diseases that have been shown to lead to wound healing disorders (e.g. diabetes mellitus, malignancies, HIV, radiation, immunosuppression)
Addresses
Primary Sponsor
- Address:
- Poliklinik für Parodontologie, Zentrum für Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang-Goethe Universität Frankfurt am MainTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-frankfurt.de/carolinum/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Poliklinik für Parodontologie, Zentrum für Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang-Goethe Universität Frankfurt am MainDr. Hari PetsosTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- 00496963015642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-frankfurt.de/carolinum/
Contact for Public Queries
- Address:
- Poliklinik für Parodontologie, Zentrum für Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang-Goethe Universität Frankfurt am MainDr. Hari PetsosTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- 00496963015642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-frankfurt.de/carolinum/
Principal Investigator
- Address:
- Poliklinik für Parodontologie, Zentrum für Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang-Goethe Universität Frankfurt am MainDr. Hari PetsosTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- 00496963015642
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-frankfurt.de/carolinum/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Poliklinik für Parodontologie, Zentrum für Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang-Goethe Universität Frankfurt am MainTheodor-Stern-Kai 760596 Frankfurt am MainGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-frankfurt.de/carolinum/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-03-12
- Ethics committee number:
- 2021-140
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-05-03
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The data can be requested from the study director.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry