An interventional study of Vital root resection in Periodontitis and Furcation Defects, sponsored by University of Santiago de Compostela. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by University of Santiago de Compostela · Not applicable, Interventional, and Treatment
The primary aim of this study is to evaluate 1-year survival of maxillary molars with subclass C vertical furcation involvement after vital root resective therapy
Schedule of Treatment for each visit:
Visit 1 - Baseline (day 0)
Visit 2 - Treatment (intervention) visit
Visit 3 - 1 Week Post-Intervention and Further Treatment
Visit 4 - 1-Month Post-Intervention
Visit 5 - 3 Months Post-Intervention
Visit 6 - 6 Months Post Intervention
Visit 7 - 9 Months Post Intervention
Visit 8 - 12 Months Post Intervention
Description of study procedures:
Clinical periodontal examination:
Dichotomous (no/yes) full mouth plaque scores (FMPS) will be recorded, identifying tooth surfaces revealing the visual presence of plaque following the use of plaque-disclosing tablets. Periodontal measurements will be taken by the calibrated examiner at six sites per tooth using a manual University of North Carolina (UNC-15) periodontal probe. The following periodontal measurements will be taken full mouth at 6 sites per tooth: probing pocket depth (PPD), recession of the gingival margin from the cemento-enamel junction (CEJ), dichotomous (no/yes) bleeding on probing (BoP). Recession will be recorded as a negative number if the gingival margin is above CEJ; and as a positive number (incl. 0) if margin is on (0) or below CEJ (>0). Further, tooth mobility (no/yes and degree 1, 2 or 3), horizontal furcation involvement using a Nabers probe (no/yes and degree 1, 2 or 3) and finally vertical furcation involvement (no/yes and class A, B or C) measured with a UNC-15 probe will be recorded. Clinical attachment levels (CAL) will be calculated as PPD + recession. This is part of standard care.
Sensitivity testing:
Cold stimulus (Endo-Frost; Roeko GmbH \& Co - Coltène-Whaledent, Switzerland) will be applied on a sprayed cotton pellet to the cervical third of the buccal and palatal surfaces of isolated teeth after gentle air-drying and for up to 10 seconds per tooth. A negative response will be recorded when the subject fails to indicate a response on two consecutive occasions on each surface.
Electric testing will be carried out following manufacturer instructions by placing the toothpaste-impregnated probe tip to the occlusal third of the tooth. A plastic interproximal matrix band will be used between teeth to prevent current conduction to the adjacent teeth. A negative response will be recorded when the tester reaches its maximum level on two consecutive occasions.
Root-resective surgery:
Following rinsing with chlorhexidine digluconate 0.12% mouthwash (Perio-Aid; Dentaid, Spain) and administration of local anaesthetic (Xilonibsa 20 mg/ml + 0,0125 mg/ml; Inibsa SA), intrasulcular and/or submarginal incisions will be performed as judged by the clinician. Releasing incisions may be performed if necessary. Full-thickness flaps will be elevated to access the furcation area. Granulation tissue will be eliminated with the aid of curettes (Hu-Friedy Manufacturing Co LLC), and root surface debridement will be performed with ultrasonic devices (EMS, Switzerland) with specific thin and delicate inserts and/or curettes. The root scheduled for resection will be separated from the root using high-speed rotary instruments. Once complete root separation is verified, it will be carefully elevated from the socket. Additional cuts in the separated root may be performed as necessary in order to minimise trauma to the socket and the tooth. Following root resection, the tooth will be isolated with rubber dam and a light-cured resin barrier (Opaldam, Ultradent Products) to avoid contamination of the pulpal wound. A 3-mm amputation of the pulp will be carried out with sterile round diamond burs under water cooling, to allow space for both pulp capping and restorative material. Pressure will be applied on the exposed pulp for up to 5 minutes with a sterile cotton pellet soaked in 2.5% NaOCl to achieve hemostasis. The exposure cavity will be filled with Biodentine (Septodont, Saint Maur des Fossés, France) following manufacturer's instructions on material manipulation and placement. After initial setting of the capping material (12 minutes from mixing), a rubber dam will be placed in order to isolate the resection site and avoid moisture, and 1 mm of Biodentine will be removed with a sterile tungsten carbide bur at low speed (5000-10000 rpm) under copious irrigation. A self-etching dentine adhesive (Clearfil SE Bond; Kuraray, Osaka, Japan) will be applied to the cavity and subsequently restored with a light-cured resin composite (Clearfil AP-X; Kuraray, Osaka Japan). Finishing and polishing of the restoration will be accomplished with a very fine diamond bur. Careful recontouring of the resection area will be performed in order to avoid ledges or plaque-retentive anatomy. Bone resection will be performed with rotary and manual instruments as judged by the clinician. Flaps will be will be repositioned and sutured with 5/0 and 6/0 monofilament sutures (Seralene; Serag-Wiessner GmbH \& Co. KG). Gentle pressure will be applied with a moist gauze until haemostasis is achieved.
Follow-up Procedures:
All sites in the mouth of participants will receive the required periodontal treatment by a trained therapist (periodontist/dentist/hygienist) throughout the duration of the study, as judged by the examining clinician. This is likely to involve supportive periodontal therapy (including supra- and sub-gingival debridement, polishing, oral hygiene re-enforcements and motivation) but may also involve more advanced periodontal treatment including surgical options. If any participant-related acute medical or dental problems arise, these will be managed in the appropriate manner in line with routine clinical practice. Where appropriate, if care is required in relation to one of the study treatment procedures, participants will be seen at the study site. In other cases, following an assessment of the most appropriate treatment required, participants will be appropriately directed to their medical or dental general practitioner.
At the study completion phase the patient may be further allocated for treatment if it is deemed necessary. If no such treatment is required then the patient will be enrolled in a supportive periodontal therapy program.
'Rescue' therapy: In case of continued CAL >2mm at 2 consecutive appointments, an extra session of sub-gingival debridement under local anaesthesia or an access flap operation will be planned for the study site, as judged by the examining clinician. In case of development of endodontic pathology: consider endodontic therapy (if indicated) or otherwise extraction (if combined with mobility > I). In the case of a development of root fracture or in cases of excessive mobility or patient discomfort, extraction will be considered and discussed with the patient. Any further treatment carried out on the molar with FI will be recorded and analysed. If any extraction is carried out, the reason for extraction will be documented in the case-report forms.
In case endodontic pathology developed, the patient will be provided endodontic treatment.
Radiographic Assessments:
The selected study defect will be detected based on radiographs often taken at the new patient consultation or provided by referring dentists. A long-cone periapical radiograph of selected study sites will be taken by one of the study investigators at baseline, 6 and 12-month follow-up visits. Additional radiographs may be taken when considered clinically necessary by the treating clinician.
These radiographs are considered standard of care as they will be important for treatment planning purposes and for assessing the treatment response. They will also help decide whether or not the teeth are still maintainable post-treatment.
A preoperative limited-volume CBCT will be taken in order to assess root morphology and presence of periapical pathology. A follow-up CBCT scan will be taken at 12 months in order to assess the presence of periapical pathology and intra-pulpal calcifications in reaction to the treatment.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 10 is below the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of Santiago de Compostela is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Patient:
Molar affected by FI:
Root resective surgery aiming to preserve pulp vitality
Procedure: Vital root resection
Vital resection of root with attachment loss exceeding 2/3 of the root with the use of calcium silicate cement in the pulpal wound
Tooth survival
Tooth present or absent after treatment (yes/no)
Time frame: 1 year
Probing pocket depth
Distance from gingival margin to deepest point of the pocket
Time frame: 1 year
Clinical attachment levels
Distance from CEJ to deepest point of the pocket
Time frame: 1 year
Radiographic bone levels
Periapical radiographs and/or CBCT
Time frame: 1 year
Pulpal response to sensitivity tests
Positive or negative response to electric and cold pulp tests (yes/no). Cold stimulus (Endo-Frost; Roeko GmbH \& Co - Coltène-Whaledent, Switzerland) will be applied on a sprayed cotton pellet to the cervical third of the buccal and palatal surfaces of isolated teeth after gentle air-drying and for up to 10 seconds per tooth. A negative response will be recorded when the subject fails to indicate a response on two consecutive occasions on each surface. Electric testing will be carried out following manufacturer instructions by placing the toothpaste-impregnated probe tip to the occlusal third of the tooth. A plastic interproximal matrix band will be used between teeth to prevent current conduction to the adjacent teeth. A negative response will be recorded when the tester reaches its maximum level on two consecutive occasions.
Time frame: 1 year
Clinical signs or symptoms indicative of periapical pathology
Periapical radiolucencies, sinus tract, swelling, tenderness to percussion, coronal discolouration, pain on biting, cold and heat lingering sensitivity, persistent or spontaneous dull throbbing pain
Time frame: 1 year
Formation of calicified tissue in the pulp exposure
Presence or absence of radio-opaque area over pulp exposure assessed on CBCT (yes/no)
Time frame: 1 year
Tooth mobility
Yes/no
Time frame: 1 year
Further treatment needed
e.g. repeated instrumentation, prosthetic intervention, etc
Time frame: 1 year
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Dec 2024, 33 months after the start.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 33 months is above that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Santiago de Compostela